System and method for detecting target substances

ABSTRACT

A method includes capturing a signal of a detection substrate exposed to a sample containing a target substance; determining that the detection substrate is in a testable state; and generating an assessment of the presence of the target substance in the sample.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation-In-Part Application of U.S.application Ser. No. 14/498,298, filed on 26-Sep.-2014, which isContinuation-In-Part Application of U.S. application Ser. No.14/227,543, filed on 27-Mar.-2014, which claims the benefit of U.S.Provisional Application Ser. No. 61/874,590, filed on 6-Sep.-2013, andU.S. Provisional Application Ser. No. 61/806,425, filed on 29-Mar.-2013,which are each incorporated herein in their entirety by this reference.This application claims priority to U.S. Provisional Application No.62/234,751 filed 30-Sep.-2015, which is incorporated in its entirety bythis reference.

TECHNICAL FIELD

This invention relates generally to the consumer assay device field, andmore specifically to an improved system and method for detection oftarget substances within a consumable.

BACKGROUND

A wide variety of consumables (e.g., foods, beverage, cosmetics, etc.)contain contaminants, toxins, allergens, and/or other substances thatare of interest to all or specific types of consumers. In particular, inrecent years, an increase in the number of consumers with an identifiedallergy (e.g., gluten allergy, dairy allergy, fish allergy, nut allergy,soy allergy, cosmetic allergy, etc.) has contributed to a number ofproducts that omit ingredients having an associated allergen; however,such consumers are still at risk for consuming items with a harmfulsubstance when the items do not have adequate labeling or documentation.Various systems and methods exist for detection of toxins and harmfulsubstances present in a sample; however, current systems and methods aredeficient due to one or more of: a time-intensive manner of receivingtest results, a labor-intensive manner of receiving test results, anon-automated manner of processing samples, system bulk, systemnon-portability, and other factors that contribute to inconveniencing aconsumer using such systems.

Due to these and other defects of current systems and methods fordetecting harmful substances in consumables, there is thus a need for animproved system and method for detecting target substances. Thisinvention provides such a system and method.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 depict an embodiment of a system for detection of harmfulsubstances;

FIGS. 2A and 2B depict embodiments and variations of a portion of asystem for detection of harmful substances;

FIGS. 3A and 3B depict cross sectional views of an example of a portionof a system for detection of harmful substances;

FIG. 4 depicts an example of a portion of a system for detection ofharmful substances;

FIGS. 5A and 5B depict variations of a valve mechanism in an embodimentof a system for detection of harmful substances;

FIGS. 6A-C depict example distributions of scattered light at avariation of a detector of an example optical sensing subsystem of anembodiment of a system for detection of harmful substances;

FIG. 7 depicts example image intensity data included in embodiments ofsystems and/or methods for detection of harmful substances;

FIGS. 8A-C depict variations and configurations of a portion of a systemfor detection of harmful substances;

FIG. 9 depicts one variation of a portion of a system for detection ofharmful substances;

FIGS. 10A and 10B depict example outputs of a system for detection ofharmful substances;

FIGS. 11A-B depict example outputs of a system and/or method fordetection of harmful substances;

FIG. 12 depicts a flowchart of an embodiment of a method for detectionof harmful substances;

FIG. 13A-C depict example outputs of portions of an embodiment of amethod for detection of harmful substances;

FIG. 14 depicts a schematic of an embodiment of a system for detectionof harmful substances;

FIG. 15 depicts an example output of a portion of an embodiment of amethod for detection of harmful substances;

FIG. 16 depicts an example output of a portion of an embodiment of amethod for detection of harmful substances;

FIG. 17 depicts an example output of a portion of an embodiment of amethod for the detection of harmful substances;

FIG. 18 depicts an example output and/or input of a portion of anembodiment of a method for detection of harmful substances;

FIG. 19 depicts a variation of a system for detection of harmfulsubstances;

FIG. 20 depicts a variation of an analysis module for detection ofharmful substances;

FIG. 21 depicts a variation of an analysis module for detection ofharmful substances; and

FIG. 22 depicts an example distribution of radiant intensity produced bya variation of a portion of an embodiment of a system for the detectionof harmful substances.

FIGS. 23A and 23B depict a perspective and side view of an example ofthe optical subsystem.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following description of preferred embodiments of the invention isnot intended to limit the invention to these preferred embodiments, butrather to enable any person skilled in the art to make and use thisinvention.

1. Overview

As shown in FIG. 1, an embodiment of a system 100 for detecting a targetsubstance in a consumable sample includes: a test container 105 and ananalysis device 205 configured to detect presence of the harmfulsubstance at the test container 105. In an embodiment, the testcontainer 105 includes: a sample processing chamber 110 for receivingand processing the consumable sample, and a detection substrate 150fluidly connected to the sample processing chamber for detection of theharmful substance. In an embodiment, the analysis device 205 includes: ahousing 210 configured to receive the test container 105, a mixingmodule 230 configured to mix the homogenized sample within the testcontainer with a process reagent, an optical sensing subsystem 220mounted to the housing and configured to enable detection of presence ofthe harmful substance at the detection substrate 150, and a processingand control system 240 configured to receive and process signals fromthe optical sensing subsystem 220, thereby producing an outputindicative of presence of the harmful substance in the consumablesample.

The system 100 functions to receive and process a sample of a consumable(e.g., food, beverage, cosmetic, etc.), and detect the presence of atarget substance in the sample. In examples, the target substances canbe a harmful substance, and can include any one or more of: an allergen(e.g., gluten allergen, a dairy-derived allergen, a nut allergen, a fishallergen, an egg-derived allergen, etc.) a toxin, a bacterium, a fungus,a pesticide, a heavy metal, a chemical or biological compound (e.g., afat, a protein, a sugar, a salt, etc.), and any other suitable harmfulsubstance. In alternative examples, the target substance can be a benignsubstance, or any other desired target substance found in consumables.The system 100 is preferably configured to impose minimal requirementsupon a consumer using the system 100, in terms of labor-intensiveness,time-intensiveness, and cost-intensiveness. As such, the system 100 ispreferably configured to automatically or semi-automatically process thesample in a manner that is intuitive to the consumer, and to quicklyprovide information regarding presence of the harmful substance(s)within the sample. The system 100 is preferably configured to providerepeatable and reliable results to the consumer, to preventfalse-positive and false-negative detection of target substances, and toavoid misinterpretation of the results by the consumer. As such, thesystem 100 is preferably configured to automatically interpret thesignals received from the optical sensing subsystem, and toautomatically provide the output indicative of the presence of thetarget substance to the consumer. The system 100 is preferablyconfigured to be portable and compact, such that the user canconveniently carry the system 100 during his/her daily life (e.g., toestablishments); however, in some alternative variations, the system 100can be configured to be non-portable and/or non-compact. Preferably, thesystem 100 has reusable and disposable components, and in somevariations portions of the system 100 are configured to be single-use(e.g., the test container(s), portions of a test container, thedetection substrate) while other portions of the system 100 areconfigured to be reusable (e.g., the analysis device). However, in othervariations, the system 100 can include only reusable components or onlydisposable components.

In an example workflow utilizing the system 100, the system 100 isconfigured to receive a sample at a sample processing chamber 110 of atest container 105, to homogenize the sample, to mix the homogenizedsample with at least one process reagent, to flow the homogenized sampleto a beginning portion of a detection substrate 150, to capture an imageof the detection substrate 150 with an optical sensing subsystem 220,and to process the captured image to enable detection of one or moreharmful substances within the sample at an analysis device. In theexample workflow, a user of the system 100 would deposit the sample intothe test container, perform a small amount of labor to facilitatehomogenization of the sample, and place the container in the analysisdevice for further processing and analysis of the sample, such that theuser has minimal interaction with the system 100 in generating anoutput.

As shown in FIG. 14, in another example workflow, the system 100 canfunction to mix the homogenized sample (e.g., where the system 100 isconfigured to rotate a mixing element located within the sampleprocessing chamber of the test container) with the appropriateprocessing reagents, to flow the consumable sample to a beginningportion of a detection substrate 150 (e.g., test strip), to performoptical analysis with an optical sensing subsystem 220 of acomplementary analysis device 205, and to display results on a userinterface 250 (e.g., an indicator of whether or not allergens weredetected). In this example workflow, the optical analysis would beperformed by the processing module of the analysis device, and caninclude capturing a plurality of images of the detection substrate atvarious time points, as well as performing various image processingroutines on each captured image (e.g., convolution, averaging,thresholding, peak detection, calibration, etc.) in generating anoutput.

As such, the system is preferably configured to facilitateimplementation of the method 300 described in Section 4 below; however,the system 100 can additionally or alternatively be configured toperform any other suitable method.

2. Benefits

In specific examples, the system 100 and/or method 300 can conferseveral benefits over conventional methodologies used for detectingtarget substances in a sample. For example, conventional methodologiesfor allergen testing (e.g., mass spectroscopy, PCR techniques, standardELISA, etc.), can be expensive, not currently suitable for consumer use,involve many processing steps, are unable to detect target proteins(e.g., that can cause an allergic response), have results that aredifficult to interpret (e.g., requiring specialized knowledge), are notrobustly effective for various sources of target substances, and/or havelimited accuracy. In specific examples, the system 100 and/or method 300can perform one or more of the following:

First, the technology can provide an intuitive, consumer-friendlyallergen testing device for detecting allergens in consumable sampleswhile requiring minimal human interaction with the device. For example,the technology can perform detection of potentially life-threateningallergens while only asking the user to insert a consumable sample(e.g., a food sample, a drink sample, etc.) into a test container, sealthe test container, and place the test container into an analysisdevice, which subsequently performs an automated analysis of the sampleto determine the presence of the allergen of interest.

In a specific example, the action of placing the test container into theanalysis device can cause the processing module of the analysis deviceto (1) control the mixing module to mix the homogenized sample withprocessing reagents to produce a mixed liquid sample, which thencontacts the detection substrate and flows laterally along the detectionsubstrate, (2) capture an image of the exposed detection substrate usingthe optical sensing subsystem of the analysis device, and (3) processthe captured image in order to detect the presence of the allergen ofinterest. Automating the interpretation of the results of the lateralflow assay can improve the accuracy and repeatability of the analysis,thereby reducing risk to the consumer of encountering a harmfulallergen. In another specific example, the test container can define akeyed profile with asymmetric sides and/or ends of the test container,thereby ensuring that the test container can only be inserted into theanalysis device in a single direction and/or angular orientation andthat the detection substrate is thus correctly oriented for imagecapture and processing by the analysis device. Further, the technologycan possess a form factor and design enabling discreteness and/orportability. For example, the technology can be handheld, mobile and/orpossess a footprint enabling the technology to be easily transported(e.g., in a purse, in a pocket, in a backpack, etc.) for on-the-goallergen testing (e.g., at a restaurant, at a workplace, etc.).

Second, the technology can quickly provide allergen testing results soas to provide a seamless eating experience. In a specific application,the technology can provide an indication and/or an analysis of presenceof gluten in a food sample on the order of minutes (e.g., less than 3minutes), using an improved allergen extraction process, streamlined andautomatic sample processing, and an improved analysis protocol (e.g.,using a detection substrate on which regions exposed to the allergen ofinterest absorb a specific frequency of light, and exposing thedetection substrate to light of predominantly that frequency andmeasuring the quantity of light absorbed by the substrate). However,variations of the specific application can additionally or alternativelyinvolve detection of any other suitable type or number of allergens(e.g., gluten allergen, a dairy-derived allergen, a nut allergen, a fishallergen, an egg-derived allergen, a soy derived allergen, apeanut-derived allergen, shellfish-derived allergens, etc.) and/or anyother substances of interest in a consumable sample, within any othersuitable time frame, and/or using any other suitable substance indicatormodule.

Third, the technology provides an efficient, user-friendly device whiledetecting allergens with high specificity. In a specific application,the test container and analysis device can identify if a consumablesample has 20 parts per million (ppm) or more of gluten. Additionally oralternatively, the technology can identify any suitable combination orconcentration of allergens, in order to detect allergens at aspecificity matching FDA guidelines for restaurants to label consumablesas free of a given allergen. Further, the technology can detect withsuch specificity while requiring a minimal amount of consumable sample,so as to not significantly remove portions of the consumable for otherpurposes (e.g., consumption).

Fourth, the technology can be designed to achieve the above-mentionedfunctionality while retaining an unobtrusive design. For example, themorphological form of a test container can be reduced by efficientlypositioning and orienting components within the test container, whilestrategically directing sample flow through the components of the testcontainer. In a specific example of efficient positioning of components,a capillary-flow based detection substrate can be positioned laterallyadjacent to a grinding chamber situated above a mixing chamber. In aspecific example strategic directing of sample flow, the flow caninclude gravitationally driven flow along both the longitudinal axis andlateral axis of the test container in order to leverage both downwardgravitational flow and upward capillary flow. Further, the technologycan be assembled with materials complementing the strategic design. Forexample, the analysis device(s) and/or test container(s) can incorporatedouble shot plastics to improve durability while retainingfunctionality.

The technology can, however, provide any other suitable benefit(s) inthe context of detecting target substances in consumable and/ornon-consumable samples.

3. System

As discussed above, the system can include: a test container 105 thatincludes: a sample processing chamber 110 for receiving the consumablesample, generating a homogenized sample upon processing of theconsumable sample, combining the homogenized sample with a processreagent to produce a dispersion, and exposing the dispersion to adetection substrate 150 for detection of the harmful substance.

The consumable sample is preferably a food sample potentially containinga harmful substance (e.g., an allergen), and is preferably anunprocessed food sample, such that the user can gather an insubstantialvolume of a food substance that he/she intends to consume for a meal,and deliver it into the sample processing chamber no of the testcontainer 105 for processing and analysis. In this example, the foodsample can include a mixture of different food items (e.g., differentcomponents of an entrée), can include a single food item (e.g., a singlecomponent of an entrée), and/or can include a sequence of different fooditems (e.g., a sequence of components from an entrée). The food samplecan be cored, spooned, tweezed, and/or processed from a bulk volume offood in any other suitable manner. However, in variations, theconsumable sample can include any one or more of a: beverage sample(e.g., volume of a mixed drink), cosmetic substance (e.g., volume ofmakeup, volume of lotion, volume of fragrance, volume of soap, etc.),and any other sample potentially containing a substance that is harmfulto the user. In variations, the consumable sample can have a volume ofbetween 1 and 7mL prior to processing within the sample processingchamber no; however, the consumable sample can alternatively have anyother suitable volume.

The test container 105 can be configured to couple to an analysis device(e.g., to cooperatively form an aligned system). In a specific example,the aligned system of the test container 105 coupled to the analysisdevice 205 can be characterized by a length less than 4 inches (e.g., alength of 3.5 inches), a width less than 1.5 inches (e.g., a width of1.0 inches), and a height less than 3.5 inches (e.g., a height of 3.1inches). In this specific example, the analysis device can possesssubstantially similar dimensions. In another specific example, the testcontainer can be defined by a height less than 3 inches (e.g., a heightof 2.5 inches). However, any suitable component of the system 100 canpossess any suitable dimensions.

Components of the system 100 can be assembled and/or coupled (e.g.,coupling between the test container 105 and the analysis device 205,coupling between components of the test container 105, coupling betweencomponents of the analysis device 205, etc.) using sealants, pressfitting, interference fits, tongue-and-groove interfaces, threadedinterfaces, adhesives, ultrasonic welding, clips, and/or any othersuitable mechanism.

In variations where the test container 105 can couple with the analysisdevice 205 in an alignment configuration 211 of an aligned system, thesystem 100 preferably operates when the system 100 is stood up on thebase of the analysis device 205 (e.g., with the base physically againsta non-system surface such as a table; with the base arranged at anon-zero angle to a gravity vector; etc.), as opposed to if the system100 is lying on its face (e.g., a triangular face physically connectedto the base of the analysis device 205; with the base arrangedsubstantially parallel a gravity vector; etc.). Additionally oralternatively, the system 100 is operable in any orientation in thealignment configuration 211.

In relation to a weight of the system 100, components of the system 100can have any suitable weight. In a specific example, the analysis devicecan possess a weight less than 2.5 oz, and the test container canpossess a weight less than 0.85 oz, but any suitable component can haveany suitable weight characteristic. Regarding materials of the system100, components of the system 100 can be constructed with materialsincluding: glass, metal, ceramic, plastic, or any other suitablematerial or combination thereof. In a specific example, components ofthe system 100 can be constructed using double shot plastics to enabledurability.

In a variation, components of the system 100 can be waterproof and/orwater-resistant. In an example, components of the system 100 withsurfaces exposed to interaction with a consumable sample can be coatedwith a water-repellant coating. In another example, the system 100 caninclude waterproofing sealants such as gaskets, o-rings, and/or othersuitable waterproofing components. In a specific example, the testcontainer 105 can include a waterproofing sealant arranged at the firstchamber 111 along the circumference of the consumable reception opening112, such that waterproofing sealant can act as a sealing intermediarybetween the first chamber 111 and the driving element 120 in response tocoupling of the a first chamber 111 and the driving element 120 by theuser. Additionally or alternatively, components of the system 100 canmaintain functionality upon exposure of different components of thesystem to different types of consumable samples (e.g., of varyingviscosity, chemicals, liquid, solid, gas, etc.). However, the system 100can include any suitable waterproofing element and components of thesystem 100 can have any suitable resilience.

However, the system 100 can possess any suitable mechanicalcharacteristic.

3.1 System—Test Container

As noted above and shown in FIGS. 1 and 2A-2B, in an embodiment, thetest container 105 includes: a sample processing chamber 110 and adetection substrate 150. In variations, the test container 105 canadditionally or alternatively include: first chamber 111, a secondchamber 112, an analysis chamber 115, and a detection window 117. Thetest container 105 can additionally or alternatively include anysuitable components.

The test container 105 functions to receive the consumable sample,generate a homogenized sample upon processing of the consumable sample,combine the homogenized sample with a process reagent to produce adispersion, expose the dispersion to the detection substrate 150, andprovide optical access to the detection substrate for use and analysisby an associated analysis device 205.

In variations, the test container 105 can be a test container asdescribed in U.S. patent application Ser. No. 15/265,171 filed on14-Sep.-2016, the entirety of which is incorporated herein by thisreference and hereinafter referred to as US Application No. USApplication No. '171. However, the test container 105 may be any othersuitable test container having some or all of the features described indetail below, and the test container 105 and/or components of the testcontainer 105 can possess any suitable characteristics.

3.1. A Test Container—Sample Processing Chamber

The sample processing chamber 110 functions to receive and facilitateprocessing of a consumable sample that the user intends to analyze forpresence of a harmful substance (e.g., an allergen). The sampleprocessing chamber 110 preferably includes an analysis chamber 115,which contains the detection substrate 150 and which preferably includesa transparent detection window 117 that provides optical access to thedetection substrate 150. The sample processing chamber 110 can alsoinclude: a first chamber 111 that functions to receive the consumablesample and in which the consumable sample is ground (e.g., transformedfrom an inhomogeneous consumable sample to a homogenized sample using aburr grinder), and a second chamber 112 into which the homogenizedsample is transferred, and in which the homogenized sample is mixed withone or more process reagents to form a dispersion that is brought intocontact with the detection substrate 150 for detection of the substance.

The sample processing chamber no preferably defines a consumable samplefluid path through each of the first, second, and analysis chambers ofthe test container 105 between the consumable reception opening 112 andthe detection substrate. The consumable sample can preferably becharacterized by different phases (e.g., solid phase, liquid phase,gaseous phase) throughout the sample fluid path. For example, a solidconsumable sample can be received at an opening of the sample processingchamber. Upon grinding of the solid consumable sample into a homogenizedsample, and mixing of the homogenized consumable sample with at leastone process reagent, the consumable sample is preferably in a liquiddispersion phase for transfer to a detection substrate 150. However, theconsumable sample can have any suitable phase along the sample fluidpath. Consumable sample and/or other fluid flow through the sample fluidpath can be gravitationally driven, magnetically driven, capillarydriven, hydrostatically driven, pressure driven, and/or driven throughany suitable mechanism. However, the sample and/or the sample fluid pathcan have any suitable flow characteristics at any point along theconsumable sample path.

The sample processing chamber preferably receives a consumable sample byway of a consumable reception opening substantially as described in USApplication No. '171, incorporated above, but can additionally oralternatively receive the consumable sample in any suitable manner.

In variations including a first chamber 111 and second chamber 112, thefirst and second chamber are preferably configured substantially asdescribed in US Application No. '171, incorporated above, but canadditionally or alternatively be configured to augment processing of theconsumable sample in any suitable manner. The processing and transfer ofthe consumable sample in and between each of the subchambers of thesample processing chamber 110 (e.g., the first chamber 111, the secondchamber 112, the analysis chamber 115) is preferably performedsubstantially as described in US Application No. '171, but canadditionally or alternatively be performed in any suitable manner andusing any suitable components, as described in US Application No. '171or otherwise.

In some variations, the sample processing chamber 110 and/orsubchamber(s) thereof (e.g., the second chamber 112) can include amixing element 1101 that functions to facilitate mixing of thehomogenized sample with a process reagent within the sample processingchamber no. The mixing element 1101 can be disposed within the secondchamber 112, and/or can be coupled to the sample processing chamber noin any other suitable manner. The mixing element 1101 is preferablyconfigured to cooperate with a mixing module 230 of an analysis device205, as described in further detail below, such that the mixing element1101 and the mixing module 230 complement each other to provide a mixingmechanism within the second chamber 112; however, variations of thesystem 100 can entirely omit the mixing element 1101 and/or the mixingmodule 230 and facilitate combination of the homogenized sample with theprocess reagent in any other suitable manner (e.g., the process reagentcan be combined with the consumable sample during processing within thefirst chamber 111). In variations, the mixing element 1101 can provideany one of: a magnetically-driven mechanism of mixing, an ultrasonicmechanism of mixing, a vibration-based mechanism of mixing (e.g.,mechanically driven, acoustically driven), a rocking motion, aspinning-based mechanism of mixing (e.g., by forming a vortex), ashaking-based mechanism of mixing, and any other suitable mechanism ofmixing. In an example, as shown in FIG. 4, the mixing element 1101includes a magnet 135 (e.g., magnetic stir bar) configured within thesecond chamber 112 that is configured to magnetically couple to acomplementary magnet of a mixing module 230. In the example, thecomplementary magnet can be coupled to a spinning motor, therebyproducing rotation at the magnet 135 within the second chamber 112. Invariations of the example, the magnet 135 can include a permanent magnetand/or an electromagnet. Furthermore, the magnet 135 can be a distinctelement within the second chamber 112, or can additionally oralternatively be coupled to or integrated with a diaphragm 160configured to access the second chamber 112, as described below.Furthermore, variations of the example can include any suitable numberof magnets 135 of the second chamber 112.

In variations, the second chamber 112 can be prepackaged with theprocess reagent (e.g., where the second chamber 112 houses a processingreagent), such that the homogenized sample is automatically brought intocontact with the process reagent upon transmission between the firstchamber 111 and the second chamber 112. Additionally or alternatively,the second chamber 112 and/or any other suitable portion of the testcontainer 105 can include or be coupled to a fluid delivery module(e.g., of the analysis device 205, of the test container 105, etc.) forreception of the process reagent and combination of the process reagentwith the homogenized sample or the consumable sample. For instance, theprocess reagent can be delivered from a module integrated with one ormore portions of the driving element 120 (e.g., from the plunger 128,from beneath the grinder 122), such that the process reagent does notoriginate from within the second chamber 112. As such, mixing of theconsumable sample with a process reagent can occur prior to grinding ofthe consumable sample by a driving element 120.

The process reagent preferably includes an extraction solutionconfigured to extract at least one analyte, associated with a harmfulsubstance, from the homogenized sample, that can be detected at adetection substrate and used to indicate presence of the harmfulsubstance. In an example for gluten detection, the extraction solutioncan contain 2-mercaptoethanol, or tris(2-carboxyethyl)phosphine, whichoperates by reducing disulfide prolamin crosslinking in a sample, andsolubilizes proteins in the sample to facilitate detection. Theextraction solution can additionally or alternatively contain guanidinehydrochloride, or N-lauroylsarcosine, or other disaggregating agents. Invariations for other allergens, the extraction solution can includeethanol for a dairy-derived allergen (e.g., lactose), a parvalbuminextraction solution for a fish-derived allergen, an ara-h2 extractionsolution for a nut derived allergen, an egg protein extraction solutionfor an egg-derived allergen (e.g., ovomucoid protein, ovalbumin protein,ovotransferrin protein, lysozyme protein), a tropomyosin extractionsolution for a shellfish-derived allergen, and/or any other suitableextraction solution for any other harmful substance. Furthermore,variations of the process reagent(s) can additionally or alternativelyinclude any one or more of: a reagent for lysing of a sample, a reagentfor solubilization of a sample, a reagent for buffering of a sample, areagent for dilution of a sample, and any other suitable reagent(s). Forinstance, in some variations, extraction and dilution of a sample togenerate a dispersion can involve a first process reagent for extraction(e.g., an alcohol-based solution for extraction of gluten), and a secondprocess reagent for dilution of a sample processed with the firstprocess reagent, such that the dispersion has appropriatecharacteristics for assessment at a detection substrate 150.

In variations, the second chamber 112 can be prepackaged (e.g., prior toreceipt of a consumable sample through the consumable reception opening112) with one or more mixing elements 134 (e.g., magnets, etc.), inorder to facilitate mixing of processing reagent and the consumablesample upon receipt of the consumable sample in the second chamber 112.The one or more mixing elements 134 can be prepackaged with or separatedfrom processing reagent and/or other suitable components. However, thesecond chamber can house any suitable components prior to, during,and/or after receipt of the consumable sample at any suitable componentof the test container 105.

The outlet port 136 functions to facilitate delivery of a controlledvolume (and/or rate of flow) of the dispersion, from the second chamber112, to an analysis chamber 115 for detection of the harmfulsubstance(s) within the consumable sample. The outlet port 136 ispreferably situated at an inferior portion of the second chamber, anexample of which is shown in FIG. 2B, in order to facilitate delivery ofthe dispersion from the second chamber at least in part by gravity.However, the outlet port 136 can alternatively be configured at anysuitable location relative to the second chamber. The outlet port 136preferably allows a volume of the dispersion to be transmitted to adetection substrate 150 at an analysis chamber 115 in communication withthe port, wherein the volume of the dispersion is configured so as toprovide an adequate amount of the dispersion without flooding thedetection substrate. In a specific example, an outlet port 136 of thesecond chamber 112 can be sized to be impermeable to residual particlesresulting from the breaking of a frangible region 161 of the diaphragm160 when the diaphragm is detachably coupled to the interior wall of thetest container body. However, the outlet port can have any suitabledimensions.

While the outlet port 136 can be configured to passively facilitatedelivery of the dispersion to a detection substrate at the analysischamber 115, variations of the system 100, as shown in FIG. 6A and FIGS.5A and 21, can include an actuation system 137 configured to provide ormeter a controlled volume of the dispersion to the analysis chamber 115.In one variation, an actuation system 137 coupled to the outlet port 136can include a valve 138 that can be controllably opened and/or closed inorder to dispense the dispersion into the analysis chamber 115 with acontrolled volume and/or at a controlled time point. In an example, thevalve 138 can include a rod 31 (e.g., needle) that is biased to beclosed in a first valve configuration 32 and configured to open in asecond valve configuration 33, wherein transitioning between the firstvalve configuration 32 and the second valve configuration 33 can becontrolled by actuators (e.g., solenoids, etc.) of the test container105 and/or analysis device 205, pressurization of the test container 105(e.g., using a pneumatic mechanism), and/or in any other suitablemanner. In the example, the rod can be biased closed using a compressionspring (or other elastomeric element), and configured to transitionbetween the first valve configuration 32 and the second valveconfiguration 33 upon user input (e.g., by pushing a button on the testcontainer or the analysis device, by inputting a command at a userinterface, etc.) and/or automatically (e.g., controlled by a controllerof the system loo).

In another example, the outlet port 136 can include a material valve 138configured to transition from a first state 34 to a second state 35(e.g., reversibly, irreversibly), thereby allowing a volume of thedispersion to pass through the outlet port 136 in a controlled manner.In variations of this example, the material of the valve 138 can includeany one or more of: a material (e.g., salt, sugar, polyvinyl alcohol,etc.) configured to transition from a solid state to a dissolved state(e.g., dissolvable salt wall, dissolvable in a manner that does notaffect detection of an analyte at the detection substrate), a waxconfigured to transition from a solid state to a melted state, amaterial (e.g., foil, metals, plastics, etc.) configured to transitionfrom an unpunctured state to a punctured state, and/or any othermaterial configured to transition between states without affecting testresults (e.g., without interfering with the delivery of a volume of adispersion to a detection substrate, etc.). The transition between afirst material valve configuration (e.g., closed) to a second materialvalve configuration (e.g., open, facilitating delivery of a volume ofthe dispersion) is preferably controlled by a component (e.g., amechanical actuator, a heating element, a fluid dispersion moduledispersing fluid for dissolving the material valve, etc.) of theanalysis device 205. In a specific example, the analysis device 205 caninclude a valve motor coupled to a valve plunger that manipulates a raketo pierce with a seal of the outlet port 136 in order to open the valvehole and transition the outlet port from a first to a secondconfiguration. However, valve-controlling components of the analysisdevice 205 can apply any suitable force, movement, and/or action inopening and/or closing pathways through the outlet port 136. However,the transition from the first to the second valve configuration can alsobe controlled by components of the test container 105, actions by theuser, and/or any through any other suitable mechanism.

In another example, the outlet port 136 can be characterized by varyinglevels of permeability to the consumable sample, homogenized sample,liquid dispersion, components of the test container 105 (e.g., diaphragm160, residual pieces from a broken frangible region of the diaphragm160, etc.), and/or other suitable materials of the test container top106 and/or sample, depending on the configuration state (e.g., betweenan open and a closed configuration) of the outlet port 136. In aspecific example where the second chamber 112 includes an outlet port136 including a valve 138, the analysis device 205 can include a valvemotor that controls the valve 138 of the outlet port 136 to operatebetween: a closed position where the outlet port 136 is impermeable toflow of the consumable sample through the outlet port 136, and an openposition wherein the outlet port 136 is permeable to the flow of theconsumable sample through the outlet port 136, and impermeable tomovement of the magnetic diaphragm 160′ through the outlet port 136. Inspecific examples, the outlet port can include flow passage features toenable and or prevent flow of sample and/or other components. The outletport can define protrusions, standoffs, biofilms, fluid blocking agents,damming agents, features affecting fluid dynamics, standoffs, and/or anyother suitable features affecting sample flow through the outlet port136. In an illustration, the outlet port 136 can include a flowregulator (e.g., a foam dam) to regulate the flow of the dispersionand/or other suitable component to the detection substrate 150. The flowregulator is preferably arranged at an interface between the outlet port136 and the detection substrate 150, but can be otherwise positioned inrelation to the outlet port 136. The flow regulator can preferablyretain a specific volume of the dispersion and/or facilitate thedelivery of a specific volume of the dispersion to the analysis chamber115. However, the outlet port 136 can possess and/or be defined by anysuitable flow passage characteristics.

In another example, the outlet port 136 can define (e.g., along with afirst chamber 111, a second chamber 112, an analysis chamber 115, etc.)a sample fluid path through which a consumable sample would travelduring operation of the test container 105 with the analysis device 205in the alignment configuration 211. The outlet port 136 can beappropriately dimensioned to define a specific fluid path. As shown inFIG. FIG. 19, for example, the outlet port 136, can be defined by testcontainer body interior walls that are straight, angled, curved, and/orwith any suitable orientation to define a corresponding sample fluidpath. In a specific example, the outlet port 136 of the second chamber110 can define a sample fluid path extending along a lateral axis of thetest container body, but can otherwise define sample fluid paths alongany suitable reference feature (e.g., any suitable axis, plane, angle,etc.) of the test container body. In specific examples, the outlet port136 can define microfluidic pathways configured to transfer theconsumable sample from the second chamber 112 to one or more suitablecomponents (e.g., an analysis chamber 115, a chamber for furtherprocessing, etc.). However, the outlet port can be otherwise configuredfor defining a sample fluid path.

In another example, the outlet port 136 can be appropriately dimensioned(e.g., based upon the viscosity of the dispersion) to allow thecontrolled volume of the dispersion to pass into the analysis chamber115. In variations of this example, positive pressure and/or negativepressure can also be used to drive the dispersion out of the port andinto the analysis chamber.

In still another example, the outlet port 136 can include a valve 138(e.g., a membrane, a film) that can be punctured or otherwisecompromised to allow a volume of the dispersion to pass through theoutlet port 136 and into the analysis chamber 115. In this example, thevalve 138 could be compromised using a needle coupled to a portion ofthe second chamber, wherein the needle could be deflected (e.g., by aportion of the analysis device 205, in combination with spring-loadingof the needle) in a manner that prevents accidental deflection by a useror other entity in contact with the test container 105. As such, theactuation system 137 can operate as a release mechanism that allows thedispersion to be conducted to a detection substrate at the analysischamber 115. The outlet port 136 and/or actuation system 137 can,however, be configured in any other suitable manner and/or include anyother suitable elements that enhance detection at a detection substrate.For instance, one variation of the outlet port 136 can include a filterproximal the port that prevents material (e.g., material that couldadversely affect detection) from passing into the analysis chamber 115and/or from reaching the detection substrate 150.

However, the second chamber 112 and/or components of the second chamber112 can be configured in any suitable manner.

The analysis chamber 115 functions to position a detection substrate 150proximal the outlet port 136 of the second chamber, such that thedetection substrate 150 can absorb a volume of the dispersion andprovide indication of presence of at least one harmful substance withinthe consumable sample. The analysis chamber 115 is preferably coupled toat least one of the second chamber 112 and the first chamber, and in onevariation, the analysis chamber 115 is configured external to the secondchamber 112, with access between the second chamber 112 and the analysischamber 115 provided by the outlet port 136 of the second chamber 112.In an example of this variation, the analysis chamber 115 can include aslot longitudinally spanning a portion of the test container 105, asshown in FIG. 2B, wherein the slot is configured to position thedetection substrate 150 proximal the outlet port 136. Portions of theanalysis chamber 115 and/or components of the analysis chamber 115(e.g., detection substrate 150) are preferably aligned, adjacent, and/orproximal along a lateral axis of the first chamber 111 and/or secondchamber 112, but can be in any suitable configuration with any suitablecomponent. However, the analysis chamber 115 can alternatively beconfigured in any other suitable manner.

3.1.B Test Container—Detection Substrate

The detection substrate 150 functions to indicate presence of ananalyte, associated with a harmful substance, and in variations, canindicate presence based upon one or more of: a color change,fluorescence emission, infrared emission, magnetic response, electricalresponse, acoustic change, and any other suitable mechanism ofindication. The detection substrate 150 is preferably a permeablesubstrate (e.g., test strip) that soaks up a portion of the dispersionand facilitates binding of one or more analytes in the dispersion withcomplementary antibodies (e.g., antibodies bound to cellulose nanobeads)at the detection substrate 150, to provide indication of presence ofharmful substances associated with the analyte(s). The detectionsubstrate 150 can include a single active region (e.g., a band, a line,a dot, etc.) for analyte binding, or a set of active regions for analytebinding. The active region(s) can include antibody cocktails for asingle analyte associated with a harmful substance, a set of analytesassociated with different harmful substances, and/or a control regionconfigured provide a control readout (e.g., in order to enabledetermination of a baseline signal, in order to establish properconductance of a test). For instance, in some variations of a detectionsubstrate 150 with a set of active regions 151 for analyte binding, oneactive region can be used as a test region that is used to indicate anamount (e.g., concentration, volume, mass) of a harmful substance in aconsumable sample, and another active region can be used as a controlregion that indicates that the test has been performed properly (i.e.,such that data generated from the detection substrate 150 is reliable).The detection substrate 150 preferably includes a beginning region andan end region respectively defining the beginning and end portions of asample fluid path through the detection substrate 150. In a specificexample, the analysis chamber 115 can include a detection substrate 150extending along a longitudinal axis of the test container body, thedetection substrate 150 including a beginning region fluidly connectedto the second chamber 112, and an end region proximal the first chamber111. However, the beginning and end regions of a detection substrate 150can have any suitable positional relationship with other components ofthe test container 105. In some variations, the detection substrate caninclude multiple regions aligned along the longitudinal axis. In aspecific example, the detection substrate can include, in order of fluidflow (e.g., from upstream to downstream): a test region, a hook region,and a control region. This configuration can function to detect smallamounts of the target (e.g., due to the test region being first), and todetermine that the sample has flowed through the majority of thedetection substrate (e.g., due to the control region being last).However, the detection substrate can be otherwise configured.

In variations, a region of a detection substrate 150 can be configuredto accommodate an analyte with a single binding site, or multiplebinding sites (e.g., as in a sandwich assay having a first antibody thatserves as a capture antibody, and a second antibody that serves as ananalyte-specific antibody). However, the detection substrate 150 canadditionally or alternatively include any other suitable liquid mediumor sensor configured to indicate presence of a harmful substance withinthe consumable sample in any other suitable manner. In an example, thedetection substrate 150 is a long, narrow, and flat strip of a fibrousmaterial with regions (e.g., bands, lines, spots) of complementaryantibodies to an analyte associated with a harmful substance, wherebycapillary soaking of the detection substrate 150 distributes thedispersion across the detection substrate 150. In a version of theexample for gluten testing, the detection substrate 150 includes acontrol band and a test band, having a distribution of a G12 antibody,bound to cellulose nanobeads, which is configured to bind to the 33-merpeptide of the alpha-gliadin molecule in gluten.

In a variation, the analysis chamber 115 can include a detectionsubstrate 150 including microfluidic pathways, including channels on apatterned-paper, lab-on-a-disc, lab-on-a-chip, and/or any other suitablemicrofluidic devices facilitating detection of target substances in theconsumable sample. Additionally or alternatively, the analysis chamber115 and/or detection substrate 150 can include any suitable elementsdescribed in U.S. application Ser. No. 15/065,198, filed 09-Mar.-2016,which is herein incorporated in its entirety by this reference.

In some variations, the analysis chamber 115 can include a detectionwindow 117 that enables detection of presence of a harmful substance atthe detection substrate 150. As such, the detection substrate 150 can beconfigured to align with the detection window, such that indicators(e.g., one or more lines generated during binding of analyte at thedetection substrate) can be observed through the detection window 117.The detection window 117 can substantially span an entirety of thedetection substrate, or can alternatively be configured to selectivelyprovide observation of one or more regions of interest of a detectionsubstrate 150. The detection window can optionally function as and/orprovide reference point(s) for image analysis, wherein all or a portionof the detection window is imaged with the detection substrate. Thedetection window 117 can be defined by an opening through the analysischamber 115, and can additionally or alternatively include a covering(e.g., transparent covering, translucent covering) that enablesobservation of the detection substrate 150. Alternatively, the detectionwindow can be a unitary piece with the test container housing, whereinthe housing is made of a clear material and can optionally beselectively masked to prevent light contamination or for other purposes.In variations, the detection window 117 can further function to indicatepotential defectiveness of a test container 105, detection substrate150, and/or any other suitable portion of the system 100 in providingreliable results. For instance, in some variations, wherein detectionsubstrates are sensitive to heat and/or humidity, the detection window117 can be configured to indicate subjection of a detection substrate150 to high temperatures (e.g., above 40° C.) and/or humid environments(e.g., by producing a color change in the detection window, by havingthe detection window fog up, etc.). Additionally or alternatively, thetest container 105 can be coupled with a dessicant to preventhumidity-induced damage, and furthermore, variations of the detectionwindow 117 can additionally or alternatively provide any other suitablefunction that provides information regarding potential defectiveness ofa test performed using the detection substrate 150, defectiveness inanalyte detection, and/or any other suitable function. For instance, thedetection window 117 can provide optical qualities that provide desiredproperties upon illumination in order to enhance analysis of a detectionsubstrate 150. Variations of the analysis chamber 115 can, however,entirely omit the detection window 117. For instance, a variation of thesystem 100 can be configured such that the detection substrate isretrieved after contacting a volume of the dispersion, and analyzed awayfrom an analysis chamber 115 of a test container 105.

In variations with a detection window 117, the detection window 117preferably constructed with materials and or sealants preventing liquid(e.g., dispersion, consumable sample, etc.) from unintentionally leakingfrom the test container 105 (e.g., onto other components of the testcontainer 105, onto the analysis device 205). The detection window 117is preferably coupled to the remaining test container 105 with a sealant(e.g., heat seal), but can additionally or alternatively be coupled tothe test container through adhesives (e.g., UV glue), press fitting(e.g., ultrasonic), and/or any other suitable mechanism. The detectionwindow 117 is preferably made of a rigid material (e.g., brittleplastic, plastic blend, etc.) that prevents a user from piercing thedetection window 117. Additionally or alternatively, the detectionwindow 117 can be made of a softer material and/or any other materialpossessing any suitable characteristic. In providing modularity, thedetection window 117 can be made of multiple components and/ormaterials. For example, the detection window 117 can include a rigidcomponent to prevent user penetration and a softer component tofacilitate penetration by the valve plunger. However, the detectionwindow can be assembled with any suitable materials and/or sealants.

Variations of the test container 105, as noted earlier, can becharacterized by modularity in using a combination of reusable and/ornon-reusable components, such that portions of the test container 105can be reused, and other portions of the test container 105 can bedisposed after a limited number of uses. For instance, in somevariations, all portions of the test container 105 can be configured tobe reusable, aside from the detection substrate iso/analysis chamber115, such that the detection substrate 150 are disposed after each use,and the test container 105 can be reused for another instance ofdetection upon replacement of the detection substrate iso/analysischamber. In other variations, all portions of the test container 105 canbe configured to be reusable, aside from the detection substrate 150,such that the detection substrate 150 is disposed after each use, andthe test container 105 can be reused for another instance of detectionupon replacement of the detection substrate 150. The test container 105can, however, provide any other suitable combination of reusable anddisposable components. In providing modularity, portions of the testcontainer 105 are preferably made of a material that is recyclable,compostable and/or processable, and in variations, can include any oneor more of: a polymer (e.g., a plastic), a metal, and a glass. Forexample, a portion of the test container 105 can be made of acompostable material, while the detection window 117 of the testcontainer can be made of a recyclable plastic. However, variations ofthe test container 105 can alternatively include any other suitablematerial (e.g., ceramic), and can be configured to be entirely reusableor entirely disposable.

3.1.0 Test Container—Test Container Body

As shown in FIG. 19, the test container can additionally oralternatively include a test container body, which functions to providemechanical support and/or shielding to components of the test container105. The test container body can include a test container top io6, atest container bottom 107 opposing the test container top 106, and/orany suitable number of side walls 108 physically connecting the testcontainer top 106 and the test container bottom 107. However, the testcontainer body can include any suitable components in any suitableconfiguration.

As shown in FIG. 19, in a variation, the test container body can bekeyed (e.g., possess an asymmetric profile) for insertion into theanalysis device 205. This can function to facilitate reliable,repeatable test container alignment in a desired orientation within theanalysis system, which can be desirable when the detection substrate isasymmetrically arranged on the test container and/or when the opticalsystem is asymmetrically located in the analysis chamber. This profilemay not be as advantageous if the detection substrate extends about theperimeter of the test chamber, or if the test container is inserted intoa test lumen surrounded by optical sensors.

For example, the test container 105 can include a curved side wall 108′and a flat side wall 108″. In another example, the test container bodycan define a test container top geometrically asymmetric from a testcontainer bottom. In a specific example, the test container body candefine a curved side 108′ physically connected to the test container top106 and the test container bottom 107, wherein the curved side isproximal the first chamber 111 and the second chamber 112 of the testcontainer 105. In this specific example, the test container body canadditionally or alternatively define a flat side 108″ opposing thecurved side 108′ and physically connected to the test container top 106and the test container bottom 107, wherein the flat side 108″ isproximal and/or forms the analysis chamber. In another example, the testcontainer 105 can define a cross section including a tongue,complimentary to a groove defined by the analysis device opening.However, the test container body can be configured in any suitablemanner.

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the embodiments of the test container 105 withoutdeparting from the scope of the test container 105.

3.2 System—Analysis Device

As noted above and shown in FIG. 1, in an embodiment, the analysisdevice 205 includes: a housing defining a test container lumen 210 and acomponent volume 222, the test container lumen configured to receive atest container 105; a mixing module 230 configured to mix thehomogenized sample in the associated test container 105 with a processreagent, an optical sensing subsystem 220 mounted to the housing withinthe component volume and configured to enable detection of presence ofthe harmful substance at the detection substrate 150, and a processingand control system 240 configured to receive and process signals fromthe optical sensing subsystem 220, thereby producing an outputindicative of presence of the harmful substance in the consumablesample.

3.2.A Analysis Device—Test Container Lumen

The test container lumen 210 functions to receive the test container105, and can additionally function to align the test container 105 tofacilitate detection of analytes at a detection substrate, incooperation with the optical sensing subsystem 220. The test containerlumen 210 preferably defines a test container opening sized to receivethe test container 105. As such, the test container lumen 210 preferablymates with the test container 105 (e.g., an external morphology of thetest container 105), in a consistent manner, such that the testcontainer 105 can only be positioned within the test container lumen 210of the analysis device in one of a discrete set of orientations (e.g.,in variations wherein the test container 105 has an orientation). In aspecific example, the test container lumen can be geometricallycomplementary to the test container 205, where the test container lumen210 can include a superior portion geometrically complimentary to a testcontainer top 106, and an inferior portion geometrically complimentaryto a test container bottom 107. Alternatively, in variations wherein thetest container 105 is symmetric (e.g., having a rotational axis ofsymmetry), the test container lumen 210 can be configured to accommodatesymmetry in the test container 105 in relation to positioning the testcontainer 105 relative to other elements of the analysis device 205(e.g., the optical sensing subsystem 220, the mixing module, 23o). Whilethe test container lumen 210 can receive a test container 105 into aninterior portion of the analysis device 205, test container lumen 210can additionally or alternatively be configured to couple the testcontainer 105 to an external portion of the analysis device 205. Forinstance, the test container lumen 210 can include a mechanism (e.g.,latch, slide, magnet) configured to couple the test container 105 to atleast a portion of the exterior of the analysis device 205.

In variations where the analysis device 205 defines a base 206 and atriangular face 207, the test container opening of the test containerlumen 210 can be proximal an apex 208 of the triangular face 207.Further, a longitudinal axis of the test container lumen 210 can besubstantially parallel a side of the triangular face 207 and/or angledwith respect to the base 206 (e.g., perpendicular the base).Additionally or alternatively, a lateral axis of the test containerlumen can intersect a plane of the base 206. In this variation, a testcontainer 105 can preferably be placed at the test container openingproximal the apex 208, and the test container 105 can be guided (e.g.,slid, gravitationally driven, with guiding rails, etc.) into analignment configuration 211 with the analysis device 205. However, thetest container lumen 210 can be oriented in any suitable configurationwith respect to the analysis device 205 and/or test container 105.

As such, in some variations, the test container lumen 210 is preferablyconfigured to receive the test container 105 in an alignmentconfiguration 211, and to release the test container 105 from theanalysis device 205 in a releasing configuration 212 (e.g.,post-analysis of a sample), as shown in FIGS. 8A-8C. In producing thealignment configuration 211, the test container lumen 210 can be coupledto a cap 213 or other mechanism (e.g., latch, tab, etc.) thatfacilitates retention (e.g., locking) of the test container 105 in thealignment configuration, thereby preventing undesired deviations fromthe alignment configuration, which could affect analysis of a detectionsubstrate 150 of the test container 105. In variations of the testcontainer lumen 210 with a cap 213, the cap 213 can further function tofacilitate processing of a consumable sample and/or homogenized samplewithin the test container. For instance, in one variation, the cap 213can include an actuating element 214 (e.g., disposed within an interiorsurface of the cap 213, accessible from an exterior surface of the cap213, etc.) configured to depress a plunger 128 of the test container 105to transition a diaphragm between the first chamber 111 and the secondchamber 112 of the test container 105 between a first configuration 167and a second configuration 168, as shown in FIGS. 8A-8E. The actuatingelement 214 can be magnetically driven, pneumatically driven,mechanically driven (e.g., using springs, etc.), or driven in any othersuitable manner. Actuation of a plunger 128, as facilitated by the cap213, in this variation can be automatically performed once the testcontainer 105 is in the alignment configuration within the testcontainer lumen 210, and/or can be triggered (e.g., by the user, by acontrol system of the analysis device 205) in any other suitable manner.As such, in an example workflow of this variation, a user can place atest container 105 within the test container lumen 210 of the analysisdevice, with the consumable sample substantially homogenized and thediaphragm 160 in the first configuration 167, and closing of the cap 213can automatically initiate depressing of the plunger 128 to transitionthe diaphragm 160 into the second configuration 168 (e.g., withoutknowledge by the user). Then, after detection using the optical sensingsubsystem 220, as described below, the cap 213 can be opened and thetest container 105 can be released from the analysis device 205 in thereleasing configuration. In variations, locking and unlocking of thetest container 105 from the analysis device 205 can be manuallytriggered (e.g., by a user) through mechanical instructions (e.g., abutton, switch), audio instructions (e.g., voice control, etc.), visualinstructions (e.g., a hand gesture, etc.), touch instructions (e.g.,tap, hold, pinch, touching of a digital user interface, pushing and/orpulling force applied to the test container 105 in the test containerlumen 210, etc.), and/or through any suitable mechanism. In othervariations, locking and unlocking of the test container 105 can beautomatically triggered, for example, at specific points along thesample fluid path (e.g., after detection of one or more analytes withthe optical sensing subsystem 220, etc.), after detection of the testcontainer 105 in the test container lumen 210 (e.g., by a test containerdetection region 215 described below, etc.), and/or at any suitable timeby any suitable mechanism. However, variations of the test containerlumen 210 can alternatively omit a cap or other mechanism configured toretain the test container 105 in the alignment configuration.

As shown in FIG. 21, in another variation, the test container lumen 210can include a test container detection region 215 configured to detectthe receipt of the test container 105 at the test container lumen 210 inan alignment configuration 211. The test container detection region 215preferably includes a translucent region (e.g., constructed with glass,plastic, translucent materials, etc.) adjacent a sensor (e.g., a lightsensor, a motion sensor, etc.) of the test container detection region215. The sensor is preferably configured to determine whether a testcontainer 105 is present in the test container lumen 210 and/or whetherthe test container 105 is properly in an alignment configuration 211with the analysis device 205. Additionally or alternatively, the testcontainer detection region 215 can include any other suitable componentsfacilitating detection of the test container top 105 at the analysisdevice 205.

However, the test container lumen 210 and/or components of the testcontainer lumen 210 can be configured in any suitable fashion.

3.2.B Analysis Device—Mixing Module

The mixing module 230 functions to facilitate active mixing of ahomogenized sample of the test container 105 with a process reagent(e.g., extraction reagent), in order to produce a dispersion that can bedelivered to a detection substrate for analysis. The mixing module 230preferably operates in cooperation with a mixing element 1101 of thetest container 105 (e.g., of a second chamber 112 of the testcontainer), thereby forming a complementary portion of a mechanism thatprovides solution mixing. Thus, the mixing module 230 is preferablysituated proximal to a portion of the test container 105 having thehomogenized sample and the process reagent, in the alignmentconfiguration of the test container 105. As shown in FIG. 20, when thetest container 105 and analysis device 205 are in an alignmentconfiguration 211, the mixing module 230 is preferably partiallyencapsulated by the motor cavity 170 of the test container 105, but canadditionally or alternatively be positioned at any suitable locationrelative the test container 105 in the alignment configuration 211.

As noted above and shown in FIG. 4, the mixing module 230 can provide amagnetically-driven mechanism of mixing, an ultrasonic mechanism ofmixing, a vibration-based mechanism of mixing (e.g., mechanicallydriven, acoustically driven), a rocking motion, a spinning-basedmechanism of mixing (e.g., by forming a vortex), a shaking-basedmechanism of mixing, and any other suitable mechanism of mixing. In anexample wherein the second chamber 112 of a test container 105 includesa magnetic mixing element 1101, the mixing module 230 can include acomplementary magnet situated proximal to the second chamber 112 in thealignment configuration of the system 100. In the example, thecomplementary magnet of the mixing module can be coupled to a spinningmotor, thereby producing rotation at the magnetic mixing element 1101within the second chamber 112. In a specific example, the mixing module230 can be proximal the base 206 of the analysis device 205, and whereinthe mixing module 230 includes a complementary magnet coupleable to themagnetic element 163 of the magnetic diaphragm 160′, and a spinningmotor coupled to the complementary magnet. In variations of thisexample, the mixing module 230 can be configured to detect propercoupling between the complementary magnet of the mixing module 230 andthe magnetic mixing element 1101 within the second chamber 112 of thetest container 105 (e.g., by way of sensing of a magnetic force, by wayof detection of motion of the magnetic mixing element 1101 in responseto motion of the complementary magnet, etc.). The mixing module 230 can,however, be configured in any other suitable manner.

The mixing module is preferably controlled by the processing system ofthe analysis system, but can be otherwise controlled. The mixing modulecan include coupling sensors, which function to determine whether themixing module properly engaged the mixing mechanism within the testcontainer (e.g., force sensors depressed when the motor rotor engagesthe test container bottom, magnetic sensors or Hall effect sensors thatdetect when a magnetic element within the test container is proximaland/or is moving, etc.). The mixing module can optionally include rotaryencoders (e.g., which can be used to determine whether the mixing modulewas performing as expected), or any other suitable set of sensors. Themixing module is preferably bidirectional (e.g., operable both clockwiseand counterclockwise), but can optionally be unidirectional or actuatein any other suitable manner.

In a variation, the mixing module 230 can include a mixing status sensorconfigured to start and/or stop mixing based on a determined mixingstatus of the consumable sample in the second chamber 112. One or moremixing status sensors can include a light sensor, weight sensor, phasesensor (e.g., liquid, gaseous, solid phase), etc. Additionally oralternatively, mixing by the mixing module 230 can progress for apredetermined time period (e.g., determined by a manufacturer, by auser, etc.), an automatically determined time period (e.g., based onmixing status sensor readings), and/or for any suitable period of time.

In another variation, the mixing module 230 can include an actuationmotor coupled to a complementary magnet of the mixing module 230, andconfigured to move the complementary magnet in response to completion ofmixing in order to facilitate unimpeded flow of the liquid dispersionfrom the second chamber 112 through the outlet port 136. For example,after completion of mixing the consumable sample with processing reagentin the second chamber 112, an actuation motor of the mixing module 230can move the complementary magnet (e.g., along a guided rail) to aposition proximal a second chamber portion opposing the outlet port 136.However, the mixing module can facilitate consumable sample flow throughthe outlet port 136 in any suitable manner.

However, the mixing module 230 can be configured in any suitablefashion.

3.2.0 Analysis Device—Optical Sensing Subsystem

As shown in FIG. 21, the optical sensing subsystem 220 functions tofacilitate detection of one or more analytes, indicative of presence ofa harmful substance within a consumable sample. The optical sensingsubsystem 220 further functions to facilitate automated reading of adetection substrate 150, such that effects of user error are minimized;however, the optical sensing subsystem 220 can be configured to providemanual assessment of test results of a detection substrate 150. Theoptical sensing subsystem 220 is preferably aligned with the detectionwindow 117 of the analysis chamber 115 of the test container 105 in thealignment configuration 211, as shown in FIG. 9, in order to provide acompact configuration and facilitate direct communication between adetection substrate and the optical sensing subsystem 220. In a specificexample where the test container lumen 210 defines a first sidegeometrically complementary to a curved side wall 108′ of the testcontainer body, and an optical analysis side opposing the first side andgeometrically complementary to a flat side wall 108″ of the testcontainer body, the optical sensing subsystem 220 can be opticallyaligned with the optical analysis side of the test container lumen 210.However, in other variations, the detection window 117 of the analysischamber 115 and the optical sensing subsystem 220 can alternatively bemisaligned, and configured to communicate using elements (e.g., mirrors,etc.) that facilitate indirect communication between a detectionsubstrate 150 and the optical sensing subsystem 220. The optical sensingsubsystem 220 preferably has an adequate sensitivity, resolution, andfield of view in order to accurately and reliably detect signals from adetection substrate 150. In one variation, the sensitivity, resolution,and field of view cooperate to enable detection of a single analyte at asingle region (e.g., dot, line, band) of a detection substrate 150 andin another variation, the sensitivity, resolution, and field of viewcooperate to enable detection of multiple analytes (e.g., associatedwith different allergens) and/or control signals at multiple regions(e.g., dots, lines, bands) of a detection substrate 150. While oneoptical sensing subsystem 220 is described, the analysis device 205 can,however, include any other suitable number of optical sensors 220 tofacilitate detection of one or more analytes at one or more regions of adetection substrate 150. The optical sensing subsystem also preferablyincludes an illuminator 221 and an imager 222, as described in detail inthe following sections.

The optical sensing subsystem 220, and in particular the illuminator221, is preferably configured to generate various distributions ofradiant intensity 2211 (e.g., radiant flux) at the surface of thedetection substrate. In general, the distribution(s) of radiantintensity produced by the illuminator 221 at the surface of thedetection substrate is preferably configured to maximize the lightscattered via diffuse scattering that reaches the detector 223 of theimager 222, and to minimize the light that reaches the detector 223 viaspecular reflection off of various surfaces in the vicinity of theoptical pathway between the illuminator 221 and the imager 222 (e.g.,the detection window 117, portions of the housing 210, etc.).Additionally or alternatively, the distribution of radiant intensityproduced by the illuminator 221 can be configured to produce asubstantially uniform pixel intensity distribution at the detector 223,in the presence of a substantially uniformly absorbing and/or scatteringdetection substrate (this can, in variations, result in a substantiallynon-uniform distribution of radiant intensity due to the opticaltransfer function between the illuminator 221, detection substrate 150,and the detector 223). However, the distribution of radiant intensityproduced by the illuminator 221 can additionally or alternatively beconfigured in any suitable manner.

The distribution 2211 can be configured in several ways. Thedistribution 2211 can be configured, for example, by way of adjustingthe optical power(s) emitted by the illuminator 221. For example, thepower emitted by an end portion of the illuminator (e.g., LEDs locatedat one or both ends of an illuminator including a linear array of LEDs)can be increased relative to a center portion of the illuminator, suchthat the distribution 2211 has a greater radiant intensity at an endregion (or end regions) of the detection window than a center region.The emitted power can be static during operation of the illuminator, orit can be modulated (e.g., the power of portions of the illuminator canbe time-dependent). The distribution 2211 is preferably spatiallynon-uniform, and the spatial non-uniformity is preferably achieved bythe physical arrangement of the illuminator relative to the detectionwindow. For example, the illuminator can be separated from the detectionwindow by a spacing such that light emitted by the illuminator isconcentrated at a longitudinal edge of the detection window, resultingin an edge-oriented illumination of the detection substrate (specificexample shown in FIGS. 23A and 23B). Multiple illuminators can be spacedapart by a distance shorter than the length of the detection window, adistance longer than the detection window, or otherwise configured. Thedistribution 2211 can additionally or alternatively be configured by wayof occluding a portion of the emitted light in the vicinity of theilluminator 221, so as to “shadow” (e.g., block from directillumination) portions of the detection substrate 150 and thereby reduceunwanted reflections and/or optical noise. For example, a baffle 226(which can, in variations, be a portion of a housing of the imager 222)can extend into the optical pathway between the illuminator 221 and thedetection substrate 150 such that portions of the detection substrate150 do not receive direct illumination by the illuminator 221. In aspecific example, the imager 222 is positioned to act as a baffle 226such that a portion of the light emitted by the illuminator 221 isprevented from directly illuminating the detection substrate, and alongitudinal edge of the substrate is directly illuminated as shown inFIG. 22.

In a specific example of a distribution of radiant intensity, anilluminator 221 including two LEDs is configured to produce adistribution 2211′ such as that shown in FIG. 22, which includes twosubstantially Gaussian beam profiles. As shown, a first Gaussian beam isincident proximal a first end of the detection substrate and a secondGaussian beam is incident proximal a second end, resulting in anon-uniform radiant intensity distribution at the surface of thedetection substrate.

In a first variation, the optical sensing subsystem 220 can include animager 222 that is configured to image a detection substrate 150 throughthe detection window 117, and to generate a distribution (e.g., array)of pixel intensities corresponding to regions of the detectionsubstrate. These pixel intensities preferably correspond to theintensities of pixels of a detector 223 of the imager 222. Then, incommunication with the processing and control system 240 (described infurther detail below), the distribution of pixel intensities generatedfrom processing of a detection substrate 150 can be used to output avalue of a parameter associated with an amount (e.g., concentration inparts per million, other concentration, mass, volume, etc.) of a harmfulsubstance present in a consumable sample analyzed using the detectionsubstrate 150. An example of pixel intensity distributions, prior to andpost processing at the processing and control system 240, is shown inFIGS. 10A and 10B, respectively. The imager 222 of the first variationpreferably provides data within sufficient resolution to eliminate arequirement for tight coupling between the imager 222 and a detectionsubstrate 150; however, the imager 222 can alternatively provide datawith any other suitable resolution. The detector can, in variations,have an active surface (e.g., a surface that actively detects incidentlight) that is angled (e.g., at an oblique angle) relative to an opticalaxis between the detection window and the imager, in order to reducereflections reaching the detector from the detection window. Theresolution provided by the imager can be related to the relativearrangement of the imaging aperture of the imager, the detector of theimager, and the detection window, as well as the size of the imagingaperture and the native resolution (e.g., pixel density) of thedetector. The spacing between each of the elements along the directionof the optical path between the detection window and the detectormathematically determines the position of the detector relative to thefocal plane of the imaging aperture, and can thus result in asubstantially focused or a substantially unfocused image on thedetector. A substantially focused image at the detector preferablyenables the imager to provide an image resolution approaching the nativeresolution of the detector, whereas a substantially unfocused image canresult in “blurring” of image features in the image rendered at thedetector. In some variations, a substantially unfocused image issufficiently resolved to permit detection of image features necessaryfor substance detection, and can permit a smaller total volume occupiedby the imager.

In a specific example, the detector 223 is a CMOS linear image sensorthat includes a linear array of pixels (e.g. a 1×N array). In relatedexamples, the detector 223 can be a linear photodiode array, a linearCCD array, or a two-dimensional photodiode/CCD array (e.g., an M×Narray). The detector 223 can, however, be any suitable detector ofoptical signals.

The imager 222 can include an imaging aperture 225 that functions totransform light (e.g., rays of light) into a real image at the detector223, to enable spatially resolved detection of the received light. Theimaging aperture can be created by a mask overlaying the detector, aniris of the detector, a mask overlaying the detection window, a maskpositioned between the detector and the detection window, or otherwiseformed.

The material forming the imaging aperture is preferably impermeable to,diffuses, or absorbs a substantial amount (e.g., 75%, 80%, 90%) of thesignal measured by the detector (e.g., be black, when visible light ismeasured), but can alternatively have any other suitable properties.Examples of material that can be used include felt, paint, paper,plastic, metal, or any other suitable material. As shown in FIG. 4B, theimaging aperture acts as a focusing element for rays of light directedtowards the detector from direction of the detection window (e.g.,originating from the detection substrate) and focuses the rays into animage at the detector of the imager.

The imaging aperture 225 is preferably a slotted pinhole aperture, butcan alternatively be any suitable shape (e.g., a circular pinhole). Inthe case of a slotted aperture, the longitudinal direction of the slotis preferably substantially orthogonal to the longitudinal axis of thedetection window, but can alternatively be oriented in any suitabledirection. The imaging aperture 225 is preferably of a size or range ofsizes (e.g., 0.5 mm in diameter, 50-500 microns in diameter, etc.)enabling adequate image resolution at the detector while also reducingunwanted reflected light at the detector; however, the imaging aperture225 can be of any suitable size. The size can be a diameter or averagediameter, in the case of a symmetric aperture shape, or can includemultiple dimensions (e.g., a slotted pinhole aperture can have a widthand a height). For apertures having a height and width, the height(oriented orthogonally to the longitudinal axis of the detection windowas previously described) is preferably substantially equal to thelateral dimension (i.e., in a direction orthogonal to the longitudinalaxis) of the detection window. However, the height can be less than thisdimension, more than this dimension, or any suitable height. There ispreferably a single imaging aperture 225 that images a field of viewincluding all active regions of the detection substrate at the detector223. In other words, the field of view of the detector can be determinedby the size and/or position of the aperture (relative to the size and/orposition of the detector), which transforms the rays to form the imageat the detector as previously described. However, there canalternatively be any number of imaging apertures, each of which canimage a field of view including any suitable portion or portions of thedetection substrate. For example, the imager can include a differentaperture for each distinct region of the detection substrate, whereinthe apertures can be aligned with the anticipated locations of thesubstrate regions along the test container lumen. In variations, theimaging aperture 225 can be augmented with one or more optical elementsthat modify the image formed at the detector by the aperture (e.g., alens, f-stop, iris, grating, filter, etc.).

In a specific example, there are three slotted pinhole apertures, eachhaving a field of view corresponding to a single active region of adetection substrate having three active regions. In this example, eachslot includes a taper angle, such that the width of the slot reduces inthe direction that light travels through the slot from the detectionsubstrate 150 to the detector 223 (e.g., tapers along the thickness ofthe material defining the slot). However, in related variations, therecan be any suitable number of imaging apertures 225 that include anysuitable taper (including, for example, no taper).

In the first variation, the imager 222 can be provided along with anilluminator 221 configured to facilitate illumination of the detectionsubstrate 150, in order to enable detection of the analyte(s) at thedetection substrate. In specific examples, the illumination module caninclude one or more light-emitting diodes (LEDs) any/or any othersuitable light sources. The LEDs/light sources can be configured toprovide white light, or any suitable range of wavelengths of light.Furthermore, in variations wherein the illuminator 221 includes multiplelight sources, the light sources can be identical in output (e.g.,intensity, wavelength) or non-identical in output. As such, illuminationcan allow an intensity of a desired signal (e.g., indicative of ananalyte associated with a harmful substance) to be enhanced.Illumination can additionally or alternatively function to remove signalinterference due to inherent features (e.g., color, acidity,consistency, fermentation, hydrolyzation, etc.) of a consumable sample.For instance, pigmented and/or acidic foods can provide signalinterference in a color-based assay. As such, illumination and ordetection at a detector 223 of the imager 222 can be enabled incooperation with one or more filters (e.g., wavelength filters, emissionfilters, excitation filters, etc.) configured to filter out anyinterfering signals.

In a second variation, the detector 223 includes a photodiode system223′ configured to detect absorption and/or emission of light (e.g.,wavelengths of light) indicative of presence of (i.e., an amount of) ananalyte at a detection substrate in communication with the photodiodesystem 223′. In one variation, the photodiode system 223′ can include aphotodiode configured to detect absorption of light associated with apeak absorption wavelength of an active region of a detection substrate(e.g., in order to assess absorption at a characteristic peak absorptionwavelength of an antibody-coated bead bound to an analyte associatedwith a harmful substance). In one example for gluten detection, thephotodiode system 223′ can include a photodiode configured to detectabsorption of 555 nm light at a detection substrate, wherein cellulosenanobeads treated with a complementary antibody for gluten have anabsorption peak at 555 nm. In this example, a higher degree ofabsorption of 555 nm light (e.g., as indicated by a lower photodiodeoutput) within an active region of a detection substrate 150 isassociated with a higher concentration of gluten in a consumable sample,with an example of output data shown in FIG. 11.

In the second variation, the photodiode system 223′ can be providedalong with an illuminator 221 configured to facilitate illumination ofthe detection substrate 150, in order to enable detection of theanalyte(s) at the detection substrate. Illumination is preferablyprovided at an angle (e.g., an acute angle of incidence) relative to asurface of the detection window 117, in order to minimize reflection(e.g., from the detection window 117) that could interfere with sensingby the optical sensing subsystem 220. In specific examples, theillumination module can include one or more light-emitting diodes (LEDs)and/or any other suitable light sources. The LEDs/light sources can beconfigured to provide light associated with an absorption peak of activeparticles (e.g., antibody-coated nanobeads, colloidal gold particles) atan active region of a detection substrate 150, or any suitable range ofwavelengths of light. These particles can be either chemicallyconjugated with an antibody or more than one antibody, or can have theantibody or antibodies physically adsorbed onto them. Furthermore, invariations wherein the illuminator 221 includes multiple light sources,the light sources can be identical in output (e.g., intensity,wavelength) or non-identical in output. As such, illumination can allowan intensity of a desired signal (e.g., indicative of an analyteassociated with a harmful substance) to be enhanced. Illumination canadditionally or alternatively function to remove signal interference dueto inherent features (e.g., color, acidity, consistency, fermentation,hydrolyzation, etc.) of a consumable sample. For instance, pigmentedand/or acidic foods can provide signal interference in a color-basedassay. The signal transduction mechanism can be based on any one or moreof: absorption, fluorescence, chemiluminescence, Förster resonanceenergy transfer, electrical transduction, and any other suitable signaltransduction mechanism. As such, illumination and or detection at anoptical sensing subsystem 220 of the imager 222 can be enabled incooperation with one or more filters (e.g., wavelength filters, emissionfilters, excitation filters, etc.) configured to filter out anyinterfering signals.

The above variations of the optical sensor can be used in combinationand/or provided by the system 100 in any suitable manner. Furthermore,in variations of a detection substrate 150 having multiple activeregions, the optical sensor(s) 220 and/or illumination module(s) 222 canbe provided in units, wherein the number of units is associated with anumber of active regions in a detection substrate. For instance, for adetection substrate 150 having a control region and a test region, thesystem 100 can include two units, each having a photodiode and a lightsource (e.g., a 555 nm light source) configured to target each of thetwo active regions. In variations, however, the optical sensingsubsystem 220 can be supplemented with or replaced with any othersuitable sensor(s) configured to detect presence of an analyte basedupon one or more of: color change, spectral emission, magnetic signals,electrical current, electrical bias, acoustic signals, and any othersuitable mechanism.

3.2.D Analysis Device—Processing and Control System

The processing and control system 240 functions to receive signals fromthe optical sensor 240 and to generate an output indicative of presenceof a harmful substance within the consumable sample, based upon signalsgenerated from a detection substrate. The processing and control system240 can further function to control operation of the analysis device205, such that detection of one or more analytes associated with harmfulsubstances in a consumable sample is, at least in part, automated. Assuch, the processing and control system 240 can include a processingmodule 242 configured to receive signals from the optical sensingsubsystem 220 and a control module 244 configured to control operationof the analysis device. The processing and control system 240 ispreferably configured to implement at least a portion of the method 300,described in detail in Section 4 below, but can alternatively beconfigured in any suitable manner.

The processing module 242 is preferably configured to condition signalsgenerated at the optical sensor(s) 220, and can be directly coupled toan output of the optical sensor(s) 220. Alternatively, the processingmodule 242 can be configured to retrieve data generated from an outputof an optical sensing subsystem 220 from a storage module or in anyother suitable manner. The processing module 242 can thus be configuredto perform any one or more of: denoising, filtering, smoothing,clipping, deconvolving, standardizing, detrending, resampling, andperforming any other suitable signal-processing operation on outputsignals from the optical sensor(s) 220. In variations, wherein an outputof the optical sensing subsystem 220 is image data, the processingmodule 242 can be configured to filter and/or condition image data forsharpness, saturation, edge-finding, intensity, and/or any othersuitable image enhancement. The processing module 242 can further beconfigured to generate an analysis indicative of presence of the harmfulsubstance, wherein the analysis provides information regarding an amount(e.g., concentration, volume, mass) of the harmful substance within theconsumable sample. In one variation involving data from a photodiode,the analysis can enable identification of absorption peaks detected uponillumination of a detection substrate 150 (e.g., over time, taking intoaccount kinetics of a reaction at the detection substrate), andassociate an amount of absorption with an amount (e.g., concentration inparts per million) of an allergen present in the consumable sample. Inone variation involving image data from a camera module, the analysiscan characterize intensity (e.g., average intensity, peak intensity,relative intensity) across an active region of a detection substrate,and associate an intensity parameter (or other image parameter) with anamount (e.g., concentration in parts per million) of an allergen presentin the consumable sample. The processing module 242 can be implementedin one or more processing elements (e.g., hardware processing element,cloud-based processing element), such that processing by the system 100can be implemented in multiple locations and/or phases.

In variations, the control module 244 can be configured to control anyone or more of: retaining a test container 105 within the analysisdevice 205 in an alignment configuration, facilitating release of thetest container 105 from the analysis device 205 in the releasingconfiguration, depressing of a plunger 128 of the test container 105(e.g., to transition a diaphragm 160 of the test container 105 between afirst configuration and a second configuration), mixing of thehomogenized sample with a process reagent upon transmission of commandsto the mixing module 230, activation of a valve 138 of a second chamber112 of the test container 105 in order to initiate delivery of a volumeof a dispersion to a detection substrate 105, illumination of adetection substrate 150 upon transmission of commands to an illuminationmodule 223, transmission of outputs of an optical sensor forconditioning an processing by the processing module 240, and any othersuitable operation for automation in use of the system 100.

Modules of the processing and control system 240 can be implemented atany one or more of: on-board at the analysis device 205 that receives atest container 105, at a portion of the test container (e.g., usingelectronics integrated into the test container 105), and at any othersuitable processing subsystem. For instance, modules of the processingand control module 240 can be implemented at a mobile device (e.g.,smart phone, tablet, head-mounted computing device, wrist-mountedcomputing device) in communication with the analysis device 205, suchthat some amount of data processing and/or control of a test container105 or analysis device 205 is implemented using the mobile device.Additionally or alternatively, modules of the processing and controlsystem 240 can be implemented in any other hardware-based or cloud-basedcomputing system configured to communicate with the system 100described.

The processing and control system 240 can additionally or alternativelyinclude a communications module (e.g., a Bluetooth low energy chip) forcommunication of recorded and/or stored test results to any suitabledevice (e.g., a user device, a remote server, etc.). However, theprocessing and control system 240 can be configured in any suitablemanner.

Furthermore, the analysis device 205 can include any other suitableelements configured to facilitate processing of a test sample (e.g., adispersion generated from a consumable sample that has saturated adetection substrate), and/or reporting of information derived from thetest sample to a user or other entity. In one variation, the analysisdevice 205 can include a module configured to facilitate release of thedispersion from the port 136 of the second chamber 112 to a detectionsubstrate 150 at an analysis chamber 115, in cooperation with a valve138 of the second chamber 112, as described in relation to the port 136above. The analysis device 205 can further include elements that providean indication that the analysis device is in an operational mode (e.g.,as opposed to an off mode, as opposed to a dormant mode), and/orelements that reduce noise (i.e., signal noise, acoustic noise) duringprocessing of a test sample. The analysis device 205 can further includea housing configured to house elements of the analysis device 205 in acompact manner. The analysis device 205 or any other suitable portion ofthe system 100 can further include a power module configured to providepower to the system 100 (e.g., by including an energy storing, energyreceiving, and/or energy distributing element) such as a battery (e.g.,a rechargeable secondary battery, such as a lithium chemistry battery; aprimary battery), a piezoelectric device, and/or any other suitableenergy storage, generation, or conversion system. As shown in FIG. 14,the analysis device 205 and/or system 100 can additionally oralternatively include a display 250 (e.g., of the analysis device 205,of a mobile device in communication with the system 100) configured toconvey information (e.g., results regarding detection of a targetsubstance in the consumable sample) from the system 100 to a user orother entity, and/or any other suitable user interface elements (e.g.,input modules, notification modules, buttons 252 for initiating and/orpausing operations of the system 100, etc.) configured to facilitateuser interaction with the system 100. In a variation where the analysisdevice 205 defines a base 206 and two or more triangular faces 207connected by one or more side walls, a user interface (e.g., an LEDdisplay) can be integrated with one or more of the side walls.Additionally or alternatively, the analysis device 205 can include anyother suitable elements for processing of a test sample in a manner thatis convenient to a user.

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the embodiments of the analysis device 205 withoutdeparting from the scope of the analysis device 205.

4. Method

As shown in FIG. 12, an embodiment of a method 300 for detecting atarget substance in a consumable sample includes: at a sample analyzer,receiving an optically-derived signal of a detection substrate exposedto a sample containing a target substance S310; determining that thedetection substrate is in a testable state S320; generating anassessment of the presence of the target substance in the sample S330;and generating an output based on the assessment S340. The method 300can optionally include: receiving operation data from a component of thesample analyzer S350; and displaying the output to a user of the sampleanalyzer S360.

The method 300 functions to enable detection of one or more harmfulsubstances within a processed consumable sample. In examples, theharmful substances can include any one or more of: an allergen (e.g.,gluten allergen, a dairy-derived allergen, a nut allergen, a fishallergen, an egg-derived allergen, etc.) a toxin, a bacterium, a fungus,a pesticide, a heavy metal, a chemical or biological compound (e.g., afat, a protein, a sugar, a salt, etc.), and any other suitable harmfulsubstance. The method 300 is preferably configured to impose minimalrequirements upon a consumer using the system 100, in terms oflabor-intensiveness, time-intensiveness, and cost-intensiveness. Assuch, the method 300 is preferably configured to automatically (orsemi-automatically) process the image substantially independently fromthe consumer, and to quickly provide an assessment regarding presence ofthe harmful substance(s) within the sample. The method 300 is preferablyimplemented at least in part by the processing module and the opticalsensing subsystem of the analysis device 205 of the system 100 describedin Section 3 above; however, the method 300 can alternatively beimplemented using any other suitable system. In the following sections,a sample analyzer utilized in the method 300 can be an analysis device,such as the analysis device 205 described in Section 3 above, oralternatively any other suitable sample analyzer.

Block S310 recites: at a sample analyzer, receiving an optical signalcharacterizing a detection substrate exposed to a sample containing atarget substance. Block S310 functions to provide data characterizingthe detection substrate to a processing module of the sample analyzer,so that the data can be used in subsequent blocks of the method 300. Thesignal is preferably an image (e.g., a test image) of the detectionsubstrate, but can alternatively be any suitable signal (e.g., aphotodiode signal, a set of signals from an array of photodiodes, etc.).As such, Block S310 is preferably implemented at an embodiment,variation, or example of the optical sensing subsystem in cooperationwith the processing module described in relation to the system 100above. In a specific example, the optical signal is preferably receivedat a detector of the sample analyzer, and preferably is made up of lightscattered by the detection substrate after originating from anilluminator of the sample analyzer. In this example, the detector ispreferably angled relative to the direction from which the scatteredlight travels, in order to minimize stray light, unwanted reflections,and the like. In this example, the illuminator preferably generates anon-uniform distribution of radiant intensity at the detection substrate(e.g., an edge-oriented illumination pattern with a greater radiantintensity along a longitudinal edge region of the detection substratethan other portions of the substrate). However, Block S310 canalternatively be implemented with any other suitable system, in anysuitable manner.

Note that an image (e.g., a test image, optical signal) of the detectionsubstrate can be any data array that characterizes optical properties ofthe detection substrate, obtained by way of sensing light that has beenemitted, scattered, and/or transmitted by the detection substrate(and/or associated components, such as the detection window). Suchoptical properties can include: color, reflectivity, absorbance (i.e.,how strongly light is attenuated), birefringence, luminosity,photosensitivity, reflectivity, refractive index, scattering,transmittance, and/or any other suitable optical property. These opticalproperties are preferably represented by and directly related tonumerical values of the data array, but can alternatively be representedby any suitable values (e.g., Boolean values). The numerical values canadditionally or alternatively be indirectly related to the opticalproperties of interest; for example, the optical property of interestcan be the angle of polarization of light scattered by the detectionsubstrate, and a polarizing filter between an imager of the sampleanalyzer and the detection substrate can convert the polarization angleof the scattered light into a relative intensity which is measured atthe imager (e.g., the intensity of the light that is measured by theimager is proportional to the polarization angle of the light). Theimage is preferably spatially resolved (e.g., the data array has morethan one element in at least two spatial dimensions, and characterizesone or more optical properties in at least two spatial dimensions), butcan alternatively represent the optical properties at a single spatiallocation (e.g., a point, a single pixel, a single array element, etc.).The image can additionally or alternatively characterize non-opticalproperties (e.g., radiological properties, thermal properties,structural properties, and/or mechanical properties) of the detectionsubstrate, and be captured using any suitable non-optical detector.

Block S310 can additionally or alternatively include: capturing multipleimages, as well as capturing images corresponding to distinct regions ofthe field of view with differing integration times. The integrationtimes of images can be selected dynamically based on the content of theimage. For example, the image can contain peaks corresponding to variousactive regions on the detection substrate, each of which may result indiffering absorption strengths. In order to resolve each of the peaks ofdiffering intensity within the image data, a series of images can becaptured, each one at an integration time proportional to a backgroundintensity level in the vicinity of the peak, as shown in FIG. 16. In onevariation, the method can include recording an image of the detectionstrip, comparing the image to a reference image, increasing theintegration time if the image is below the optimal reference imagerange, and decreasing the integration time if the image is above theoptimal reference image range. This can function to position thereference image such that all bits of the image can be used.

In a specific example, capturing the optical signal (e.g., an image)includes collecting light incident upon a linear photodiode array havinga set of pixels, and outputting the test image as a data array to theprocessing module. In this example, each element of the data array has aone to one correspondence with a pixel in the set of pixels. In thisexample, the light is collected over a time period (e.g., an integrationtime), and each element of the data array contains a numerical valuethat is proportional to the amount of light collected at the linearphotodiode array sensor over the time period.

Block S310 is preferably performed substantially immediately afterinsertion of a test container into the sample analyzer, but canalternatively be performed after a delay (e.g., 10 seconds, 30 seconds,a variable time related to a time period required for mixing, etc.).S310 can be triggered by detecting the test container within the testcontainer lumen (e.g., by a contact switch, optical detector, or anyother suitable sensor), by an input provided by a user (e.g., pressing abutton that initiates image capture and sample testing), or in any othersuitable manner. In variations, S310 can occur periodically, regardlessof the presence or absence of a test container in the test containerlumen, and the image itself can be used to detect the presence of thetest container and initiate subsequent analysis. Additionally oralternatively, S310 can be performed at any suitable time or times.

Block S320 recites: in response to capturing the test image, determiningthat the detection substrate is in a testable state. Block S320functions as a preliminary check of characteristics of the detectionsubstrate, in order to determine whether the detection substrate can bereliably and accurately tested for the presence of the target substance.Block S320 is preferably implemented using embodiments, variations, orexamples of the processing module 240, the optical sensing subsystem,the detection window, orientation sensor(s), and other componentsdescribed in relation to the system 100 above; however, Block S320 canalternatively be implemented using any other suitable system. As such,in determining that the detection substrate is in a testable state,Block S320 preferably involves analyzing the captured test image;however, Block S320 can additionally or alternatively determine that thedetection substrate is in a testable state in any other suitable manner.The test image captured in S310 is preferably an image of the entireviewable area of the detection substrate, but can additionally oralternatively be of any portion or portions of the detection substrate.For example, a portion of the test image corresponding to a final activeregion along the flow path of the detection substrate (e.g., the controlline) can be used to determine that the dispersion has flowed across theentire substrate, including other active regions (e.g., the test lineand/or hook line), and thus that the detection substrate has properlydeveloped and is thus in a testable state. A testable state of thedetection substrate is preferably one or more of the following states:properly oriented within a detection window (e.g., the bounds of theactive regions are within the viewable area of the detection window),substantially undamaged (e.g., not bent, torn, ripped, broken, warped,etc.; little or no features detected in the image that substantiallymatch and/or are classified as physical strip damage; etc.), andsubstantially unsaturated (e.g., below a threshold degree of liquidsaturation). However, a testable state can be any suitable state of thedetection substrate that enables detection of the target substance.

Block S320 can include comparing the test image to a reference image, inorder to determine that the detection substrate is in a testable state.The reference image is preferably a prerecorded image stored in systemmemory, but can alternatively be a previous image of the detectionsubstrate (e.g., recorded more than a threshold time duration prior), animage of a reference strip retained within the analysis system, or anyother suitable image. The reference image is preferably an image of thedetection substrate in a testable state (e.g., undamaged, fullydeveloped, properly positioned, etc.) and comparison thereto preferablyenables the determination of the testability of the detection substrate(e.g., the test image can be determined to be substantially identicaland/or similar to the reference image of a detection substrate in atestable state, and therefore the test image can be determined to be ofa detection substrate in a testable state). Alternatively, the referenceimage can be of a detection substrate in an untestable state, and acomparison resulting in a determination that the test image issubstantially different from the reference image can lead to thedetermination that the detection substrate is in a testable state.However, test image and the reference image can alternatively becompared in any suitable manner in order to determine whether thedetection substrate is in a testable state.

In variations, Block S320 includes Block S322, which recites:determining a degree of liquid saturation of the detection substrate,recapturing the test image in response to the liquid saturation degreesatisfying a recapture condition, and determining that the detectionsubstrate is in a testable state based on the recaptured test image.Block S322 can, in examples, be referred to as performing a “slow flow”check. This can be performed a predetermined period of time after thevalve has been opened to trigger strip development (e.g., apredetermined development period, such as 60 seconds). In one variation,S322 can include recording images of the detection substrate at apredetermined frequency and analyzing each image for indicia of afully-developed strip, alignment with the reference image, and/or anyother suitable condition. The degree of liquid saturation is preferablydetermined based on background intensity values (e.g., intensity valuescorresponding to regions of the image that do not characterize activeregions, as discussed in more detail in relation to Block S330), whereinthe recapture condition is satisfied when the liquid saturation degreeexceeds a threshold (e.g., indicating excessive reflectivity of thedetection substrate related to an over-saturated state of the detectionsubstrate), but can additionally or alternatively be determined in anysuitable manner. The degree of liquid saturation can alternatively bedetermined based on whether a control line has been developed (e.g., hasreacted to the sample). The degree of liquid saturation can additionallyor alternatively be determined by comparing the test image to areference image. In such cases, the intensity of the signal of thereference and test images in regions away from the active regions (e.g.,intensity of pixels greater than ninety pixels from the edge of thepixel array) can be compared. If a large difference is detected or if aslow flow or low degree of saturation is determined, then the detectionsubstrate is permitted to develop for an additional duration of time(e.g., a delay is implemented). The delay can be calculated based on themagnitude of the difference, the determined degree of liquid saturation,the reflectivity of the detection substrate, the background intensity,or otherwise determined. The delay can be any suitable time delay, suchas 10 seconds, 30 seconds, 140 seconds, or any other suitable delay.

In variations of Blocks S310 and S322, the test image is captured at afirst time point, and S322 includes determining a delay time based onthe determined degree of liquid saturation, and recapturing the testimage at a second time point, delayed relative to the first time pointby the determined delay time. For example, a degree of liquid saturationcan be determined, and found to require a delay time of 15 seconds forthe degree of liquid saturation to be reduced below an acceptable levelfor testing, and the test image can thus be recaptured after a delay of15 seconds. However, any suitable delay time can be determined andimplemented, including a delay time of zero (indicating that the testimage does not necessarily need to be recaptured). Preferably, delayingrecapturing the test image enables excess liquid to move away from thesurface of the detection substrate under capillary action, reducing thedegree of liquid saturation. However, delaying image recapture can alsoenable the degree of liquid saturation to be reduced in any othersuitable manner (e.g., evaporation, diffusion, etc.).

In another variation, Block S320 includes Block S324, which recites:determining an orientation of the sample analyzer, and determining thatthe sample is in a testable state based on the determined orientation ofthe sample analyzer. The sample analyzer orientation can be determinedusing the orientation sensor(s) of the sample analyzer (e.g., theaccelerometer, gyroscope, IMU, etc.), or otherwise determined. In oneembodiment, the sample analyzer can be deemed to be in a testable statewhen the sample analyzer is upright (e.g., oriented upright; orientedwith the retained test container between o and 90 degrees of a gravityvector, etc.) and be deemed to be in a nontestable state when the sampleanalyzer is horizontal or otherwise arranged. Alternatively, theorientation sensor and/or other sensors of the system can be used totrigger sample mixing (e.g., the sample is mixed in response toorientation, insertion, or other preconditions being met). However, theorientation sensor can be used to determine whether the sample analyzeris in any other suitable desired configuration.

In another variation, Block S320 includes Block S326, which recites:determining a structural state of the detection substrate, anddetermining that the detection substrate is in a testable state based onthe structural state of the detection substrate. The structural statepreferably characterizes whether the detection substrate has beendamaged, altered, or become otherwise constitutionally unable to beanalyzed. As such, determining a structural state of the detectionsubstrate can include determining that it has been torn or bent throughimage recognition techniques (e.g., a distortion of the image due tobending can be recognized as such).

Block S330 recites: generating an assessment of the presence of thetarget substance in the sample. Block S330 functions to analyze thecaptured data characterizing the sample and to thereby detect thepresence of a target substance in the sample. Block S330 is preferablyimplemented using embodiments, variations, or examples of the opticalsensing system and processing module described in relation to the system100 above; however, Block S330 can alternatively be performed using anyother suitable system 100. As such, Block S330 can include receivinghomogenized portions of a consumable sample within a cavity of adiaphragm configured between the first chamber and the second chamber,and delivering homogenized portions of the consumable sample into thesecond chamber by depressing a plunger configured to contact thediaphragm. Block S330 can, however, include delivering the homogenizedsample from the first chamber to a second chamber of the test containerin any other suitable manner.

In generating an assessment in Block S330, the assessment preferablyprovides information regarding an amount (e.g., concentration, volume,mass) of the harmful substance within the consumable sample. In onevariation involving data from a photodiode, generating the assessment inBlock S330 can include identifying absorption peaks detected uponillumination of a detection substrate 150 (e.g., over time, taking intoaccount kinetics of a reaction at the detection substrate and/ordevelopment time of exposed substrate), and associating an amount ofabsorption with an amount (e.g., concentration in parts per million) ofan allergen present in the consumable sample. In one variation involvingimage data from a camera module, generating the assessment in Block S330can include characterizing intensity (e.g., average intensity, peakintensity, relative intensity) across an active region of a detectionsubstrate, and associating an intensity parameter (or other imageparameter) with an amount (e.g., concentration in parts per million) ofan allergen present in the consumable sample. Association between anamount of absorption and/or intensity is preferably performed bycomparison to a reference amount (e.g., a reference image, a lookuptable), but can alternatively be performed by comparison to an inputvalue (e.g., by a user, received from a remote portion of the processingmodule). In alternatives, the processing module of the sample analyzercan receive and store user (and/or automated) feedback as to theaccuracy of the association, and perform future associations between anamount of absorption and/or intensity and an amount of allergen by wayof machine learning (e.g., a training algorithm, neural network, etc.).In related variations, the machine learning algorithm that associatessignal values with allergen concentrations can be implemented on anetwork of processing modules, which can include the processing moduleof the sample analyzer, in order to incorporate data from a network ofusers, sample analyzers, and/or any other suitable data sources. BlockS330 can, however, include processing signals derived from a detectionsubstrate saturated with a volume of the dispersion, and/or generatingan assessment in any other suitable manner.

In variations, Block S330 can include processing the image data toenhance morphological features of the data. These morphological featuresare preferably peaks (e.g., maxima) in the data, but can additionally oralternatively be any suitable morphological features. Processingpreferably includes one or more of: background correction, filtering(e.g., kernel convolution), and dynamic-integration-time multi-imagecapture; however the image data can be processed in any suitable manner.These processing techniques are described in further detail below.

Block S330 can include processing the image data using backgroundcorrection. Background correction is preferably the subtraction of areference image (e.g., an image of an undeveloped detection substrate)from a test image (e.g., an image of a developed test substrate), inorder to enhance the relative magnitude of any signal present in thedata above the background signal level as well as to account for anyfixed-pattern noise in the image (e.g., smudges on the detection window,scratches on transparent objects in the optical path, etc.).

In variations, Block S330 can include determining (e.g., identifying,locating) portions of the image data (e.g., sets of adjacent pixels,portions of the data array, etc.) that correspond to signals collectedfrom active regions of the detection substrate S331. Block S331 canfunction to reduce the quantity of image data that is analyzed in otherblocks of the method 300 by distinguishing the portions image datacorresponding to the active regions from the portions corresponding toinactive regions (e.g., regions of the detection substrate that do notexpress a particular optical characteristic when exposed to a samplecontaining a target substance, background regions, noise regions, etc.).This can enable efficient detection of the target substance in this andother blocks of the method 300. The active regions of the detectionsubstrate are preferably active regions as described above in relationto the detection substrate 150 of the system 100, but can alternativelybe any suitable regions of the detection substrate configured to expressan optical quality of interest when the detection substrate is exposedto the sample. The detection substrate can include any number of activeregions (e.g., one, three, five, fifty, etc.), and S330 can includedetermining portions of the image data corresponding to any number ofthe active regions (e.g., all the active regions, a subset of the activeregions).

In a variation, the detection substrate can include a number of activeregions, and identifying portions of the image data corresponding to thenumber of active regions includes identifying a first portion of theimage corresponding to the first active region, and identifying theremaining portions based on a predetermined, known spacing (e.g., inunits of image pixels) between the first active region and the remainingactive regions. The first active region preferably exhibits a strong(e.g., high intensity, large absorbance) signal that enables itsefficient detection by signal processing (e.g., peak finding) techniquesdescribed in relation to this and other blocks, as well as determinationof its location within the image (e.g., in image coordinates). Forexample, the first active region can correspond to the control line ofthe detection substrate, which can be configured to generate anunambiguous signal (e.g., a strong peak of one or more orders ofmagnitude greater intensity than a typical test signal) to facilitateease of detection and/or location. However, the first active region canbe identified in any other suitable manner. In a specific example ofidentifying other portions of the image based on the location of thefirst portion corresponding to the active region, the first portion ofthe image (corresponding to a first active region) can be separated froma second portion of the image (corresponding to a second active region,such as a test region) by 20 pixels, and from a third portion of theimage (corresponding to a third active region, such as a hook region) by50 pixels; thus, the portions of the image corresponding to each of theactive regions can be determined based on the known spacing.Additionally or alternatively, other techniques can be employed todetermine one or more portions of the image data corresponding to activeregions of the detection substrate, such as peak-edge detection,thresholding, or any other suitable image and/or signal processingtechniques.

In generating the assessment, peak detection can be performed on theoptical signal and/or image data in order to identify absorption peaksand the relative locations thereof within the image data. Peak detectionis preferably performed by way of kernel convolution, but canalternatively be performed using any suitable peak-finding technique. Ina first variation, peaks are identified using kernel convolution asdepicted in FIG. 15 in which a kernel (e.g., a Gaussian kernel, aderivative of a Gaussian kernel, a top hat kernel) of a specifiedfunctional shape is convolved with the image data (e.g., by theprocessing module of the sample analyzer) in order to accentuate, andthereby detect, image features (e.g., morphological features) ofsubstantially the same shape as the kernel. One or more kernels can beused, in order to detect peaks of various shapes. In some cases, theshape of the absorbance peak can be related to the source of the targetsubstance. For example, certain consumables can be characterized bynarrow peaks present in the image data upon detection of a targetsubstance, while other consumables can be characterized by broad peaks.The kernel can thus be selected according to a known consumableundergoing analysis; additionally or alternatively, multiple kernels ofdifferent shapes (e.g., widths, functional forms) can be used, and theresults of each convolution used to determine the identity of theconsumable undergoing testing.

S330 can include peak detection, as described above, and can thusinclude Block S332, which recites: identifying a first location of apeak signal value in an upstream test image, identifying a secondlocation of a peak signal value in a downstream image, and comparing thefirst and second locations to generate a peak confidence metric. BlockS332 functions to determine if a peak signal value detected in the testimage is an accurate positive result, based on whether the location ofthe detected peak signal value is substantially the same betweenmultiple images. The peak signal value is preferably within a portion ofthe image data corresponding to an active region, having preferably beenlocated in S331, the portion having an upstream edge (e.g., a pixel ofthe image corresponding to the upstream-most edge of the active regionof the detection substrate) and a downstream edge (e.g., a pixel of theimage corresponding to the downstream-most edge of the active region ofthe detection substrate). However, the peak signal value canalternatively be within any other suitable portion of the image,corresponding to any suitable region of the detection substrate. Thepeak confidence metric can be a confidence factor (e.g., a numberbetween 0 and 1, 0% and 100%, etc.) or a binary metric (e.g., True,False), or any other suitable metric. The upstream test image can becaptured with a first integration time, and the downstream test imagecan be captured with a second integration time. In the context ofdigital imaging, integration time as used herein is, in general, thetime duration over which light is collected at the optical sensor beforebeing output as a signal. Preferably, the first integration time isrelated to a background signal level on an upstream edge of the imageportion containing the peak, and the second integration time is relatedto a background signal level on a downstream edge of the image portioncontaining the peak. The utilization of distinct integration times canenable a peak residing in a portion of the image with a non-uniformbackground signal to be efficiently identified. Alternatively, however,the integration times can be substantially identical. Alternatively, theintegration times can be dynamically adjusted (and corresponding imagessampled) until the signal from the image region substantially matchesthat of the corresponding reference image region. Preferably, any peakdetection performed in generating the assessment is associated with apeak confidence metric, in that a detected peak is preferably associatedwith a high (e.g., greater than a threshold value, such as 50%, 0.25,etc.) peak confidence metric. In some cases, an otherwise probable peak(e.g., based on the result of kernel convolution) can be discarded ifthe peak confidence metric associated with the peak is low (e.g., lowerthan a threshold value, such as 90%, 0.75, etc.). Alternatively, theassessment can be generated based at least in part on the peakconfidence metric in any suitable manner, or independently of (e.g., notbased on) the peak confidence metric. In some implementations, the imagecan be realigned relative to a reference image (e.g., the intensityvalues associated with an original set of pixel locations shifted to adifferent set of pixel locations) as a result of the peak confidencemetric, and the peak confidence metric can be determined again inrelation to the realigned image.

In variations and/or alternatives, Block S330 can include any one ormore of: denoising, filtering, smoothing, clipping, convolving,deconvolving, standardizing, detrending, averaging, resampling, andperforming any other suitable signal-processing operation on outputsignals from an optical sensor in communication with a detectionsubstrate saturated with the dispersion. In variations of Block S330involving image data, Block S330 can include filtering and/orconditioning image data for sharpness, saturation, edge-finding,intensity, and/or any other suitable image enhancement.

Block S340 recites: generating an output based on the assessment. BlockS340 functions to create a result of the assessment, and to provide theresult for use in other blocks of the method 300 (e.g., displaying theoutput S350). Block S340 is preferably implemented using embodiments,variations, or examples of the second chamber 112, the mixing element1101, and/or the mixing module 230 described in relation to the system100 described above, however, Block S340 can alternatively beimplemented using any other suitable system. The generated output can bea binary output (e.g., a positive test result, a negative test result),a ternary output (e.g., a positive test result, a negative test result,an indeterminate test result), a quantitative output (e.g., a number ofppm of the target substance detected), a combination of theaforementioned outputs (e.g., a positive test result also indicating aconcentration of the target substance), or any other suitable output.The output is preferably provided to the user of the sample analyzer,but can additionally or alternatively be stored, transmitted, oranalyzed in any suitable manner as part of S340.

Block S350 recites: receiving operation data from the sample analyzer.Block S350 functions to provide feedback data (and/or feedforward data)to other blocks of the method 300 based on operation of variouscomponents of the sample analyzer. Block S350 is preferably implementedusing embodiments, variations, or examples of the mixing module 230and/or the optical sensing subsystem 240 described in relation to thesystem 100 above; however, Block S350 can alternatively be implementedusing any other suitable system. As such, Block S350 can includereceiving operational data from sensors, the mixing module, valves,switches, or any other components related to the operation of the system100. Other blocks of the method 300 can, in turn, be performed based onthe received operation data of S350. For example, operation data caninclude data indicating that the test container has been improperlycoupled (e.g., inserted) into the sample analyzer (e.g., received by wayof a switch residing in a test container lumen of the sample analyzerconfigured to detect the presence and proper insertion of a testcontainer), and determining that the detection substrate is in atestable state S320 can be based on this operation data.

In a variation, Block S350 can include receiving mixing data from amixing module of the sample analyzer. In particular, In particular, S350can include detecting proper coupling between the complementary magnetof a mixing module and a magnetic mixing element within a testcontainer; this can be performed by way of sensing of a magnetic force,by way of detection of motion of the magnetic mixing element in responseto motion of the complementary magnet, or in any other suitable manner.Mixing data is preferably data characterizing whether mixing of thehomogenized sample was successfully performed; however, mixing data canbe any other suitable data. Successful mixing performance can be relatedto the duration for which mixing was performed by the mixing module; insuch cases, mixing data can include data indicating that the mixingmodule was operating nominally for a duration of time consistent withsuccessful mixing. Mixing data can additionally or alternativelycharacterize operating parameters of the mixing module (e.g., a timeseries signal of the power and/or current drawn by a motor of the mixingmodule), which can in turn characterize successful mixing. Preferably,the assessment generated in S330 is based on the mixing data, in that anegative test (e.g., a test indicating that no target substance wasdetected) is invalidated in the event that the mixing data indicatesthat mixing was unsuccessful. Alternatively, the integration times canbe adjusted (e.g., increased, decreased, etc.) based on the mixing data.However, the generated assessment can additionally or alternatively bebased on the mixing data in any suitable way, or the assessment can begenerated independently of (i.e., not based on) the mixing data.Received mixing data can additionally or alternatively be used toprovide feedback to the system, and/or trigger the execution ofadditional and/or existing blocks. In an example, mixing data indicatingthat the mixing was performed inadequately is received, and the mixingmodule is then controlled (e.g., by the sample analyzer and/or aprocessing module thereof) to remix the sample (e.g., perform mixing foran additional time duration). In a related example, data indicating thata motor of the mixing module has stalled (e.g., electrical current datashowing excessive current draw) is received, and in response the motoris pulsated (e.g., rhythmically, sporadically, etc.) to ensure adequatemixing. The received mixing data can additionally or alternatively beincorporated as feedback to this and other blocks in any suitablemanner.

Operation data can include orientation data, pertaining to the physicalorientation of the sample analyzer during performance of the method 300.Such orientation data can be incorporated as an input to various blocks,as a form of feedback or otherwise. In variations, orientation data caninclude the relative orientation of the sample analyzer relative to agravity vector, and can be used to determine whether the sample analyzerwas positioned substantially upright during mixing and/or detectionsubstrate development. The assessment generated in S330 can be based onthe aforementioned determination; for example, if the sample analyzer isnot upright and is a variant of sample analyzer that utilizesgravitational force to urge the sample dispersion into contact with thedetection substrate, the generated assessment may indicate that thedetection substrate was not properly exposed. The orientation data canadditionally or alternatively be dynamically incorporated intogenerating the assessment; for example, orientation data can be receivedindicating that the sample analyzer was placed on its side (e.g.,accidentally knocked over) during testing, and assessment generation canthus be restarted in response, upon proper reorientation of the sampleanalyzer.

In a related variation, received orientation data can trigger theexecution of additional and/or existing blocks of the method 300. Forexample, orientation indicating that the sample analyzer is on its side(e.g., not oriented at least partially along a gravity vector) can causea notification to be provided to a user that the sample analyzer shouldbe reoriented before testing can continue. Such a notification can beincorporated into generating the assessment as described above. Theorientation data can additionally or alternatively be incorporated intoand/or trigger any suitable blocks, in any suitable manner.

Block S360 recites: providing the output to a user of the sampleanalyzer. Block S360 functions to provide the result of the analysis toa user, in order to enable the user (e.g., consumer of the source of theconsumable sample being analyzed) to perform actions based on the result(e.g., safely consume or not consume the source of the sample). BlockS360 is preferably implemented using embodiments, variations, orexamples of the processing and control system described in relation tothe system 100 above; however, Block S360 can alternatively be performedusing any other suitable system.

4.1 Method—Specific Implementations

In a first specific implementation of the method 300, insertion data isreceived indicating that a test container has been inserted into thesample analyzer, and in response a first image (e.g., pre-image) of an(undeveloped) test strip is captured by the optical sensing subsystem ofthe sample analyzer. After receiving mixing data from the mixing moduleof the sample analyzer, indicating that the sample has been mixed andexposed to the detection substrate, a second image (e.g., post image) iscaptured. The second image is compared to the first image by subtractingthe pre image from the post image to produce a background correctedimage. If the subtraction results in a substantially zero value ofintensity in the background corrected image in a region of the imagecorresponding to a test line (e.g., one of the active regions) of thestrip, an assessment is generated that the presence of the targetsubstance has not been detected. If the subtraction results in a valueof intensity in the above image region that exceeds a threshold value(e.g., a peak is detected), an assessment is generated that the presenceof the target substance has been detected.

In a second specific implementation, a background corrected image(obtained in a manner such as described in relation to the firstspecific implementation) is filtered using a convolution filter. Infiltering the data, it is convolved with the second derivative of aGaussian kernel of a width of six standard deviations, corresponding toa wide (e.g., 20 pixels) peak. In a related implementation, the data isconvolved with a similar kernel having a width of 4 standard deviations,corresponding to a narrow peak (e.g., 10 pixels). In a further relatedimplementation, the data is convolved with both kernels as described.Examples of the shape and relative size of the described kernels areshown in FIG. 18.

While blocks of the method 300 can occur as distinct steps, in somevariations, portions of at least Blocks S310, S320, S330, S340, S350,and/or S360 can be performed substantially simultaneously. The blocks ofthe method 300 can additionally or alternatively be performed in anysuitable order. Any block can be performed based on the output of anyother block, alone or in combination.

The method 300 can additionally or alternatively include any othersuitable blocks or steps configured to facilitate detection of thepresence of one or more harmful substances within the consumable sample.

Embodiments of the system 100 and/or method 300 and variations thereofcan be embodied and/or implemented at least in part by a machineconfigured to receive a computer-readable medium storingcomputer-readable instructions. The instructions are preferably executedby computer-executable components preferably integrated with the system100 and one or more portions of the processing module 242. Thecomputer-readable medium can be stored on any suitable computer-readablemedia such as RAMs, ROMs, flash memory, EEPROMs, optical devices (CD orDVD), hard drives, floppy drives, or any suitable device. Thecomputer-executable component is preferably a general or applicationspecific processor, but any suitable dedicated hardware orhardware/firmware combination device can alternatively or additionallyexecute the instructions.

The FIGURES illustrate the architecture, functionality and operation ofpossible implementations of systems, methods and computer programproducts according to preferred embodiments, example configurations, andvariations thereof. In this regard, each block in the flowchart or blockdiagrams may represent a module, segment, or portion of code, whichincludes one or more executable instructions for implementing thespecified logical function(s). It should also be noted that, in somealternative implementations, the functions noted in the block can occurout of the order noted in the FIGURES. For example, two blocks shown insuccession may, in fact, be executed substantially concurrently, or theblocks may sometimes be executed in the reverse order, depending uponthe functionality involved. It will also be noted that each block of theblock diagrams and/or flowchart illustration, and combinations of blocksin the block diagrams and/or flowchart illustration, can be implementedby special purpose hardware-based systems that perform the specifiedfunctions or acts, or combinations of special purpose hardware andcomputer instructions.

Although omitted for conciseness, the preferred embodiments includeevery combination and permutation of the various system components andthe various method processes, wherein the method processes can beperformed in any suitable order, sequentially or concurrently.

As a person skilled in the art will recognize from the previous detaileddescription and from the figures and claims, modifications and changescan be made to the preferred embodiments of the invention withoutdeparting from the scope of this invention defined in the followingclaims.

We claim:
 1. A system for optical detection of target substances,comprising: a test container comprising: a sample processing chamber,and a detection substrate fluidly connected to the sample processingchamber; a housing defining a component volume and a test containerlumen adjacent and optically connected to the component volume through atesting window, the test container lumen configured to removably receivethe test container in an analysis configuration, wherein the detectionsubstrate is adjacent the testing window in the analysis configuration;an optical sensing subsystem mounted to the housing within the componentvolume, the optical sensing subsystem comprising: an illuminatorarranged proximal an end of the testing window and directed toward thetesting window at an oblique angle, and an imager arranged proximal acenter of the testing window with an active face directed substantiallytoward the testing window, the imager arranged between the testingwindow and the illuminator; and a processing module, configured to:record an image of the detection substrate; control the optical sensingsubsystem, based on the drive element operation data and the image ofthe detection substrate; determine a test output, based on the image ofthe detection substrate; and provide the test output to a user.
 2. Thesystem of claim 1, wherein in the analysis configuration: a longitudinalaxis of the test container is aligned at least partially with a gravityvector, and a pressure force urges a processed sample contained by thesample processing chamber into fluid communication with the detectionsubstrate.
 3. The system of claim 2, further comprising an orientationsensor, wherein the processing module is further configured to receiveorientation data from the orientation sensor; wherein the opticalsensing subsystem is controlled based on the orientation data, and thetest output is determined based on the orientation data.
 4. The systemof claim 1, wherein in the analysis configuration, the test containerand the housing cooperatively isolate the detection substrate fromambient light.
 5. The system of claim 1, wherein the illuminatorcomprises a set of light emitters, wherein each of the set of lightemitters is configured to emit light at a corresponding power levelalong a corresponding optical axis.
 6. The system of claim 5, whereinprocessing module is further configured to control the correspondingpower level of each of the set of light emitters, comprising:determining a distribution of radiant flux from the set of lightemitters; and controlling the light emitters to produce the determinedradiant flux distribution at the surface of the detection substrate. 7.The system of claim 1, wherein the imager comprises: a detectorconfigured to detect the image of the detection substrate; and animaging aperture configured to transform light scattered towards theimaging aperture from the surface of the detection substrate into theimage of the detection substrate at the detector.
 8. The system of Claim7, wherein the processing module is configured to adjust an exposuretime of the detector based on the recorded image of the detectionsubstrate.
 9. The system of claim 1, wherein the processing module isconfigured to average pixel values of adjacent pixels of the detectorand to record a spatially-averaged image of the detection substratebased on the averaged pixel values.
 10. A system for optical detectionof target substances, comprising: a detection window comprising a broadface and configured to provide optical access to a surface of adetection substrate; a set of light emitters configured to transmitlight through the broad face of the detection window and onto thesurface of the detection substrate according to an illumination pattern,the illumination pattern comprising a non-uniform distribution ofradiant flux received at the surface of the detection substrate; whereinthe non-uniform distribution comprises a radiant flux intensity that isgreater at an edge region of the detection substrate than a centerregion of the detection substrate; an imager, comprising a detector andan imaging aperture, wherein the imaging aperture is configured toproduce an image of the detection substrate at the detector based onlight emitted by the set of light emitters and scattered by thedetection substrate; and a housing statically mounting the illuminator,imager, and detection window, the housing defining an asymmetric testcontainer receptacle configured to removably receive a test containercomprising the detection substrate, the asymmetric test container keyedto align the test container in a testing configuration, wherein thedetection substrate is arranged proximal to and aligned with thedetection window in the testing configuration.
 11. The system of claim10, wherein the imaging aperture comprises a set of apertures, eachaperture configured to produce an image of a region of the detectionsubstrate at a corresponding region of the detector.
 12. The system ofClaim ii, wherein there is a one to one correspondence between each of aset of regions of the detection substrate and each of a set ofcorresponding regions of the detector.
 13. The system of claim 10,wherein the imager is positioned distal to a plane extendingperpendicularly from a midline of the broad face of the detectionwindow, and the detector is positioned at an oblique angle relative tothe broad face of the detection window, such that light specularlyreflected by the detection window does not reach the detector.
 14. Thesystem of claim 10, further comprising a baffle coupled to the set oflight emitters, wherein the baffle obstructs light specularly reflectedby the detection window and the detection substrate such that specularlyreflected light is substantially prevented from reaching the detector.15. The system of claim 10, wherein at least a subset of the set oflight emitters is partially obstructed by a portion of the imager suchthat predominantly an edge region of the detection window isilluminated.
 16. The system of claim 10, wherein the set of lightemitters comprises a first light emitter, positioned at a first end ofthe imager, and a second light emitter, positioned at a second end ofthe imager; wherein the first and second light emitters are positionedto direct light toward the detection window at an acute angle relativeto the broad face of the detection window.
 17. The system of claim 10,wherein the imaging aperture comprises a slit having a width, whereinthe width is determined according to a desired mapping between regionsof the detection substrate and regions of the detector at which theimage of the detection substrate is formed.
 18. The system of claim 17,wherein the desired mapping comprises a one to one correspondencebetween regions of the detection substrate and regions of the detector.19. The system of claim 10, wherein the non-uniform distribution isdetermined by the corresponding power level and corresponding opticalaxis of each of the set of light emitters.
 20. The system of claim 19,wherein the non-uniform distribution is determined by a relative spacingbetween each of the set of light emitters.